Singapore HSA registration DE0502861

K2M YUKON OCT Spinal System

Singapore·CLASS C·K2M, Inc.·Registered March 12, 2019

Device classification

Device Class: CLASS C
Medical Speciality Area: General Hospital

Registration information

Registration Number: DE0502861
Registration Date: March 12, 2019
Change Notification Approval Date: January 18, 2022
Retention Due Date: March 11, 2026

Product description

The YUKON OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The spinal system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Product Owner

Name: K2M, Inc.
Short Name: K2M, Inc.
Address: 600 Hope Parkway SE, Leesburg, Virginia, 20175, UNITED STATES

Registrant

Name: STRYKER SINGAPORE PRIVATE LIMITED
Address: 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145

Importer

Name: TRANSMEDIC PTE LTD
Address: 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349

Model information

Model Name(s): Parallel Connector ,Size Ø3.5-Ø5.5/6.0 mm, 4 Screw Axial Rod Connector ,Size Ø3.5 mm/Ø5.5/6.0 mm Occipital Straight Drill; Size Ø3.8 mm Occipital Straight Drill; Size Ø4.3 mm Universal Joint Drill; Size Ø3.8 mm Universal Joint Drill; Size Ø4.3 mm Polyaxial Screw ,Size Ø3.5x10 mm Polyaxial Screw, ML ,Size Ø3.5x10 mm Polyaxial Screw ,Size Ø3.5x12 mm Polyaxial Screw ML , Size Ø3.5x12 mm Polyaxial Screw ,Size Ø3.5x14 mm Polyaxial Screw ML , Size Ø3.5x14 mm Polyaxial Screw ,Size Ø3.5x16 mm Polyaxial Screw, LS ,Size Ø3.5x16 mm Polyaxial Screw ML , Size Ø3.5x16 mm Polyaxial Screw ,Size Ø3.5x18 mm Polyaxial Screw, LS ,Size Ø3.5x18 mm Polyaxial Screw ML , Size Ø3.5x18 mm Polyaxial Screw ,Size Ø3.5x20 mm Polyaxial Screw, LS ,Size Ø3.5x20 mm Polyaxial Screw ML , Size Ø3.5x20 mm Polyaxial Screw ,Size Ø3.5x22 mm Polyaxial Screw, LS ,Size Ø3.5x22 mm Polyaxial Screw ML , Size Ø3.5x22 mm Polyaxial Screw ,Size Ø3.5x24 mm Polyaxial Screw Long Shank , Size Ø3.5x24 mm Polyaxial Screw ML , Size Ø3.5x24 mm Polyaxial Screw ,Size Ø3.5x26 mm Polyaxial Screw Long Shank , Size Ø3.5x26 mm Polyaxial Screw, ML ,Size Ø3.5x26 mm Polyaxial Screw ,Size Ø3.5x28 mm Polyaxial Screw Long Shank , Size Ø3.5x28 mm Polyaxial Screw, ML ,Size Ø3.5x28 mm Polyaxial Screw ,Size Ø3.5x30 mm Polyaxial Screw Long Shank , Size Ø3.5x30 mm Polyaxial Screw, ML ,Size Ø3.5x30 mm Polyaxial Screw ,Size Ø3.5x32 mm Polyaxial Screw Long Shank , Size Ø3.5x32 mm Polyaxial Screw, ML ,Size Ø3.5x32 mm Polyaxial Screw , Size Ø3.5x34 mm Polyaxial Screw Long Shank , Size Ø3.5x34 mm Polyaxial Screw, ML ,Size Ø3.5x34 mm Polyaxial Screw , Size Ø3.5x36 mm Polyaxial Screw Long Shank , Size Ø3.5x36 mm Polyaxial Screw, ML ,Size Ø3.5x36 mm Polyaxial Screw , Size Ø3.5x38 mm Polyaxial Screw, LS ,Size Ø3.5x38 mm Polyaxial Screw, ML ,Size Ø3.5x38 mm Polyaxial Screw , Size Ø3.5x40 mm Polyaxial Screw, LS ,Size Ø3.5x40 mm Polyaxial Screw, ML ,Size Ø3.5x40 mm Polyaxial Screw , Size Ø3.5x42 mm Polyaxial Screw, ML ,Size Ø3.5x42 mm Polyaxial Screw , Size Ø3.5x44 mm Polyaxial Screw, ML ,Size Ø3.5x44 mm Polyaxial Screw ,Size Ø3.5x46 mm Polyaxial Screw, ML ,Size Ø3.5x46 mm Polyaxial Screw ,Size Ø3.5x48 mm Polyaxial Screw, ML ,Size Ø3.5x48 mm Polyaxial Screw ,Size Ø3.5x50 mm Polyaxial Screw, ML ,Size Ø3.5x50 mm Polyaxial Screw ,Size Ø4.0x10 mm Polyaxial Screw ,Size Ø4.0x12 mm Polyaxial Screw ML , Size Ø4.0x12 mm Polyaxial Screw ,Size Ø4.0x14 mm Polyaxial Screw ML , Size Ø4.0x14 mm Polyaxial Screw ,Size Ø4.0x16 mm Polyaxial Screw, LS ,Size Ø4.0x16 mm Polyaxial Screw ML , Size Ø4.0x16 mm Polyaxial Screw ,Size Ø4.0x18 mm Polyaxial Screw, LS ,Size Ø4.0x18 mm Polyaxial Screw ML , Size Ø4.0x18 mm Polyaxial Screw ,Size Ø4.0x20 mm Polyaxial Screw, LS ,Size Ø4.0x20 mm Polyaxial Screw ML , Size Ø4.0x20 mm Polyaxial Screw ,Size Ø4.0x22 mm Polyaxial Screw, LS ,Size Ø4.0x22 mm Polyaxial Screw ML , Size Ø4.0x22 mm Polyaxial Screw ,Size Ø4.0x24 mm Polyaxial Screw, LS ,Size Ø4.0x24 mm Polyaxial Screw ML , Size Ø4.0x24 mm Polyaxial Screw ,Size Ø4.0x26 mm Polyaxial Screw, LS ,Size Ø4.0x26 mm Polyaxial Screw ML , Size Ø4.0x26 mm Polyaxial Screw ,Size Ø4.0x28 mm Polyaxial Screw, LS ,Size Ø4.0x28 mm Polyaxial Screw, ML ,Size Ø4.0x28 mm Polyaxial Screw ,Size Ø4.0x30 mm Polyaxial Screw, LS ,Size Ø4.0x30 mm Polyaxial Screw, ML ,Size Ø4.0x30 mm Polyaxial Screw ,Size Ø4.0x32 mm Polyaxial Screw, LS ,Size Ø4.0x32 mm Polyaxial Screw, ML ,Size Ø4.0x32 mm Polyaxial Screw ,Size Ø4.0x34 mm Polyaxial Screw, LS ,Size Ø4.0x34 mm Polyaxial Screw, ML ,Size Ø4.0x34 mm Polyaxial Screw ,Size Ø4.0x36 mm Polyaxial Screw, LS ,Size Ø4.0x36 mm Polyaxial Screw, ML ,Size Ø4.0x36 mm Polyaxial Screw ,Size Ø4.0x38 mm Polyaxial Screw, LS ,Size Ø4.0x38 mm Polyaxial Screw, ML ,Size Ø4.0x38 mm Polyaxial Screw ,Size Ø4.0x40 mm Polyaxial Screw, LS ,Size Ø4.0x40 mm Polyaxial Screw, ML ,Size Ø4.0x40 mm Polyaxial Screw ,Size Ø4.0x42 mm Polyaxial Screw, ML ,Size Ø4.0x42 mm Polyaxial Screw ,Size Ø4.0x44 mm Polyaxial Screw, ML ,Size Ø4.0x44 mm Polyaxial Screw ,Size Ø4.0x46 mm Polyaxial Screw, ML ,Size Ø4.0x46 mm Polyaxial Screw ,Size Ø4.0x48 mm Polyaxial Screw, ML ,Size Ø4.0x48 mm Polyaxial Screw ,Size Ø4.0x50 mm Polyaxial Screw, ML ,Size Ø4.0x50 mm Polyaxial Screw, ML ,Size Ø4.5x10 mm Polyaxial Screw, ML ,Size Ø4.5x12 mm Polyaxial Screw, ML ,Size Ø4.5x14 mm Polyaxial Screw, ML ,Size Ø4.5x16 mm Polyaxial Screw, ML ,Size Ø4.5x18 mm Polyaxial Screw ,Size Ø4.5x20 mm Polyaxial Screw ML , Size Ø4.5x20 mm Polyaxial Screw ,Size Ø4.5x22 mm Polyaxial Screw, ML ,Size Ø4.5x22 mm Polyaxial Screw ,Size Ø4.5x24 mm Polyaxial Screw ML , Size Ø4.5x24 mm Polyaxial Screw ,Size Ø4.5x26 mm Polyaxial Screw, ML ,Size Ø4.5x26 mm Polyaxial Screw ,Size Ø4.5x28 mm Polyaxial Screw, ML ,Size Ø4.5x28 mm Polyaxial Screw , Size Ø4.5x30 mm Polyaxial Screw ML , Size Ø4.5x30 mm Polyaxial Screw , Size Ø4.5x32 mm Polyaxial Screw, ML ,Size Ø4.5x32 mm Polyaxial Screw , Size Ø4.5x34 mm Polyaxial Screw ML , Size Ø4.5x34 mm Polyaxial Screw ,Size Ø4.5x36 mm Polyaxial Screw, ML ,Size Ø4.5x36 mm Polyaxial Screw ,Size Ø4.5x38 mm Polyaxial Screw, ML ,Size Ø4.5x38 mm Polyaxial Screw ,Size Ø4.5x40 mm Polyaxial Screw ML , Size Ø4.5x40 mm Polyaxial Screw ,Size Ø4.5x42 mm Polyaxial Screw, ML ,Size Ø4.5x42 mm Polyaxial Screw ,Size Ø4.5x44 mm Polyaxial Screw ML , Size Ø4.5x44 mm Polyaxial Screw ,Size Ø4.5x46 mm Polyaxial Screw, ML ,Size Ø4.5x46 mm Polyaxial Screw ,Size Ø4.5x48 mm Polyaxial Screw, ML ,Size Ø4.5x48 mm Polyaxial Screw ,Size Ø4.5x50 mm Polyaxial Screw ,Size Ø5.0x20 mm Polyaxial Screw ,Size Ø5.0x22 mm Polyaxial Screw ,Size Ø5.0x24 mm Polyaxial Screw ML; Size Ø5.0x24 mm Polyaxial Screw ,Size Ø5.0x26 mm Polyaxial Screw ,Size Ø5.0x28 mm Polyaxial Screw ML; Size Ø5.0x28 mm Polyaxial Screw ,Size Ø5.0x30 mm Polyaxial Screw ML; Size Ø5.0x30 mm Polyaxial Screw , Size Ø5.0x32 mm Polyaxial Screw , Size Ø5.0x34 mm Polyaxial Screw ML; Size Ø5.0x34 mm Polyaxial Screw ,Size Ø5.0x36 mm Polyaxial Screw ,Size Ø5.0x38 mm Polyaxial Screw ,Size Ø5.0x40 mm Polyaxial Screw ,Size Ø5.0x42 mm Polyaxial Screw ,Size Ø5.0x44 mm Polyaxial Screw ,Size Ø5.0x46 mm Polyaxial Screw ,Size Ø5.0x48 mm Polyaxial Screw ,Size Ø5.0x50 mm Set Screw Head to Head Connector Set Screw Head to Head Connector Nut Occipital Screw , Size Ø4.5x6 mm Occipital Screw , Size Ø4.5x8 mm Occipital Screw , Size Ø4.5x10 mm Occipital Screw , Size Ø4.5x12 mm Occipital Screw , Size Ø4.5x14 mm Occipital Screw , Size Ø4.5x16 mm Occipital Screw , Size Ø5.25x6 mm Occipital Screw , Size Ø5.25x8 mm Occipital Screw , Size Ø5.25x10 mm Occipital Screw , Size Ø5.25x12 mm Occipital Screw , Size Ø5.25x14 mm Occipital Screw , Size Ø5.25x16 mm Occipital Screw , Size Ø5.75x6 mm Occipital Screw , Size Ø5.75x8 mm Occipital Screw , Size Ø5.75x10 mm Occipital Screw , Size Ø5.75x12 mm Occipital Screw , Size Ø5.75x14 mm Occipital Screw , Size Ø5.75x16 mm Occipital Plate , Size Occipital Plate , Size Occipital Plate , Size Straight Rod ,Size Ø4.0x120 mm Ti Straight Rod ,Size Ø4.0x240 mm Ti Transition Rod ,Size Ø4.0-5.5 mm x300 mm Ti Transition Rod ,Size Ø4.0-5.5 mm x500 mm Transition Rod; Size Ø4.0-6.0 mm x500 mm Straight Rod ,Size Ø4.0x80 mm Ti Contoured Rod; Size Ø3.5x100 mm Contoured Rod; Size Ø3.5x105 mm Contoured Rod; Size Ø3.5x110 mm Contoured Rod; Size Ø3.5x115 mm Contoured Rod; Size Ø3.5x120 mm Contoured Rod ,Size Ø3.5x25 mm Contoured Rod ,Size Ø3.5x35 mm Contoured Rod ,Size Ø3.5x45 mm Contoured Rod; Size Ø3.5x50 mm Contoured Rod ,Size Ø3.5x55 mm Contoured Rod; Size Ø3.5x60 mm Contoured Rod ,Size Ø3.5x65 mm Contoured Rod ,Size Ø3.5x75 mm Contoured Rod; Size Ø3.5x85 mm Contoured Rod; Size Ø3.5x90 mm Contoured Rod; Size Ø3.5x95 mm Contoured Rod; Size Ø4.0x120 mm Pre Bent Rod , Size Ø4.0x80-125 mm 115° Pre Bent Rod , Size Ø4.0x80-215 mm 115° Contoured Rod ,Size Ø4.0x25 mm Contoured Rod ,Size Ø4.0x35 mm Contoured Rod ,Size Ø4.0x45 mm Contoured Rod ,Size Ø4.0x55 mm Contoured Rod ,Size Ø4.0x65 mm Contoured Rod ,Size Ø4.0x75 mm Transverse Connector ,Size Hook, Ø3.5/4.0 mm Transverse Connector ,Size T-Bar, 30 mm Transverse Connector ,Size T-Bar, 60 mm Head to Head Connector Plate; (S) Head to Head Connector Plate; (M) Lateral Offset Connector, Open; Size Ø3.5/4.0 mm 10 mm Lateral Offset Connector ,Size Side Loading, 10 mm Lateral Offset Connector Side; Size 15 mm Lateral Offset Connector Side Loading Angled; Size 20 mm Lateral Offset Connector ,Size Ø3.5/4.0 mm, 30 mm, Open Head to Head Connector Plate; (L) Head to Head Connector Plate; (XL) Posterior Cervical Hook, Laminar , Size 3.5x4.5 mm Posterior Cervical Hook ,Size 3.5x6.0 mm, Laminar Posterior Cervical Hook, Laminar; Size 3.5x8.0 mm Mini Deformity Hook Angled Right; Size Ø3.5/4.0 Mini Deformity Hook Angled Left; Size Ø3.5/4.0 Mini Deformity Hook Pedicle; Size 3.5x3.5 mm Mini Deformity Hook Pedicle; Size 3.5x4.5 mm Mini Deformity Hook Pedicle; Size 3.5x6.0 mm Mini Deformity Hook Pedicle , Size 5.0x3.5 mm Posterior Cervical Hook; Size 3.5x4.5 mm TP Posterior Cervical Hook; Size 3.5x6.0 mm TP Posterior Cervical Hook; Size 3.5x8.0 mm TP Posterior Cervical Hook , Size 5.0x4.5 mm TP Posterior Cervical Hook , Size 5.0x6.0 mm TP Posterior Cervical Hook, Laminar , Size 3.5x4.5 mm ML Posterior Cervical Hook ,Size 3.5x6.0 mm, ML Laminar Posterior Cervical Hook, Laminar; Size 3.5x8.0 mm ML Posterior Cervical Hook, Laminar; Size 5.0x8.0 mm ML Posterior Cervical Hook; Size 3.5x3.5 mm ML TP Posterior Cervical Hook; Size 3.5x4.5 mm ML TP Posterior Cervical Hook; Size 3.5x6.0 mm ML TP Posterior Cervical Hook; Size 3.5x8.0 mm ML TP Posterior Cervical Hook; Size 5.0x3.5 mm ML TP Posterior Cervical Hook , Size 5.0x4.5 mm ML TP Mini Deformity Hook Infralaminar; Size 3.5x4.5 mm Mini Deformity Hook Infralaminar; Size 3.5x8.0 mm Mini Deformity Hook Infralaminar; Size 5.0x4.5 mm Mini Deformity Hook Infralaminar; Size 5.0x8.0 mm Parallel Connector, Closed; Size Ø3.5/4.0 mm, 4 Screw Parallel Connector, Closed; Size Ø3.5/4.0 mm Parallel Connector, Open/Closed; Size Ø3.5/4.0 mm Axial Connector ,Size Ø3.5/4.0 mm Parallel Connector ,Size Ø3.5/4.0 mm, Side/Closed Parallel Connector ,Size Ø3.5/4.0 mm, Side Parallel Connector Open; Size Ø3.5/4.0 mm Head Adjuster Anti-Torque Alignment Tube Forceps Rod Fork Screw Inserter Tap ,Size Ø3.0 mm Tap ,Size Ø3.5 mm Tap ,Size Ø4.0 mm Tap ,Size Ø4.5 mm Tap ,Size Ø5.0 mm Adjustable Drill ,Size Ø2.3 mm Adjustable Drill ,Size Ø2.8 mm Adjustable Drill; Size Ø3.0 mm Cervical Hook Holder Compressor Offset Hook Holder In Situ Bender In Situ Bender Rod Reducer Probe Awl Vise Grips ,Size Ø3.5/Ø4.0 mm Laminar Hook Elevator ,Size 3.5x6.0 mm Flex Shaft Drill; Size Ø3.0 mm Hook Pusher Occipital Tap / Screw Guide, Size 6/8 mm Occipital Plate Holder Occipital Plate Bender Rod Cutter ,Size Ø3.5/4.0 mm Flex Shaft Drill; Size Ø3.5 mm Distractor Occipital Anti-Torque Guide Occipital Plate Bender ,Size S Occipital Plate Bender ,Size M Occipital Plate Bender ,Size L Tap Guide Sequential Reducer Reducer Tube Tube Chuck Provisional Driver ,Size Size 15 Tapered with Handle Universal Joint Driver, Hex ,Size 20 Universal Joint Driver, Tapered ,Size 20 Universal Joint Tap ,Size Ø4.0 mm Universal Joint Tap ,Size Ø4.5 mm Universal Joint Tap ,Size Ø5.25 mm Universal Joint Driver Torque Limiting ,Size 15 Universal Joint Driver, Tapered ,Size 15 Occipital Tap ,Size Ø4.0 mm Occipital Tap ,Size Ø4.5 mm Occipital Tap ,Size Ø5.25 mm Torque Limiting Driver ,Size Size 15 Occipital Tap / Screw Guide, Size 10/12 mm Occipital Tap / Screw Guide, Size 14/16 mm Universal Joint Tap ,Size Ø5.75 mm Flex Shaft Drill; Size Ø4.0 mm Occipital Plate Template , Size Occipital Plate Template , Size Occipital Plate Template , Size Occipital Tap ,Size Ø5.75 mm 90° Driver; Size 20 Tapered 90° Driver; Size 20 Rod Bender ,Size Ø3.5 mm/ Ø4.0 mm Torque Limiting Handle 2.2N-m Mini Thoracic Probe Mini Axial AO Handle Ratchet Mini Axial AO Handle Fixed Adjustable Drill Guide ,Size 6-50 mm Occipital Awl; Size Ø2.75 mm Occipital Plate Holder Angled Nut Driver Quick Connect Adapter Plate Bender Left Plate Bender Right Plate Holder Transition Rod; Size Ø4.0-5.5 mm x500 mm Contoured Rod; Size Ø3.5x100 mm, CoCr Contoured Rod; Size Ø3.5x110 mm, CoCr Contoured Rod; Size Ø3.5x120 mm, CoCr Contoured Rod; Size Ø3.5x50 mm, CoCr Contoured Rod; Size Ø3.5x70 mm, CoCr Contoured Rod; Size Ø3.5x80 mm, CoCr Contoured Rod; Size Ø3.5x90 mm, CoCr Pre Bent Rod , Size Ø4.0x80-215 mm 115° CoCr Straight Rod, Dual Hex; Size Ø4.0x240 CoCr Straight Rod, Dual Hex; Size Ø4.0x500 CoCr
Model Identifier(s): 1101-83560A 1101-83560D 1101-90333 1101-90334 1101-90335 1101-90336 7601-03510 7601-03510M 7601-03512 7601-03512M 7601-03514 7601-03514M 7601-03516 7601-03516L 7601-03516M 7601-03518 7601-03518L 7601-03518M 7601-03520 7601-03520L 7601-03520M 7601-03522 7601-03522L 7601-03522M 7601-03524 7601-03524L 7601-03524M 7601-03526 7601-03526L 7601-03526M 7601-03528 7601-03528L 7601-03528M 7601-03530 7601-03530L 7601-03530M 7601-03532 7601-03532L 7601-03532M 7601-03534 7601-03534L 7601-03534M 7601-03536 7601-03536L 7601-03536M 7601-03538 7601-03538L 7601-03538M 7601-03540 7601-03540L 7601-03540M 7601-03542 7601-03542M 7601-03544 7601-03544M 7601-03546 7601-03546M 7601-03548 7601-03548M 7601-03550 7601-03550M 7601-04010 7601-04012 7601-04012M 7601-04014 7601-04014M 7601-04016 7601-04016L 7601-04016M 7601-04018 7601-04018L 7601-04018M 7601-04020 7601-04020L 7601-04020M 7601-04022 7601-04022L 7601-04022M 7601-04024 7601-04024L 7601-04024M 7601-04026 7601-04026L 7601-04026M 7601-04028 7601-04028L 7601-04028M 7601-04030 7601-04030L 7601-04030M 7601-04032 7601-04032L 7601-04032M 7601-04034 7601-04034L 7601-04034M 7601-04036 7601-04036L 7601-04036M 7601-04038 7601-04038L 7601-04038M 7601-04040 7601-04040L 7601-04040M 7601-04042 7601-04042M 7601-04044 7601-04044M 7601-04046 7601-04046M 7601-04048 7601-04048M 7601-04050 7601-04050M 7601-04510M 7601-04512M 7601-04514M 7601-04516M 7601-04518M 7601-04520 7601-04520M 7601-04522 7601-04522M 7601-04524 7601-04524M 7601-04526 7601-04526M 7601-04528 7601-04528M 7601-04530 7601-04530M 7601-04532 7601-04532M 7601-04534 7601-04534M 7601-04536 7601-04536M 7601-04538 7601-04538M 7601-04540 7601-04540M 7601-04542 7601-04542M 7601-04544 7601-04544M 7601-04546 7601-04546M 7601-04548 7601-04548M 7601-04550 7601-05020 7601-05022 7601-05024 7601-05024M 7601-05026 7601-05028 7601-05028M 7601-05030 7601-05030M 7601-05032 7601-05034 7601-05034M 7601-05036 7601-05038 7601-05040 7601-05042 7601-05044 7601-05046 7601-05048 7601-05050 7601-10001 7601-10002 7601-10003 7601-14506 7601-14508 7601-14510 7601-14512 7601-14514 7601-14516 7601-15206 7601-15208 7601-15210 7601-15212 7601-15214 7601-15216 7601-15706 7601-15708 7601-15710 7601-15712 7601-15714 7601-15716 7601-42432 7601-43042 7601-44050 7601-540120 7601-540240 7601-540300-55 7601-540500-55 7601-540500-60 7601-54080 7601-635100 7601-635105 7601-635110 7601-635115 7601-635120 7601-63525 7601-63535 7601-63545 7601-63550 7601-63555 7601-63560 7601-63565 7601-63575 7601-63585 7601-63590 7601-63595 7601-640120 7601-640125-115 7601-640215-115 7601-64025 7601-64035 7601-64045 7601-64055 7601-64065 7601-64075 7601-70000 7601-70001 7601-70004 7601-72131H 7601-72939H 7601-73510 7601-73510S 7601-73515S 7601-73520A 7601-73530 7601-73747H 7601-74555H 7601-80001 7601-80002 7601-80003 7601-80008 7601-80009 7601-80010 7601-80011 7601-80012 7601-80014 7601-80019 7601-80020 7601-80021 7601-80023 7601-80024 7601-80027 7601-80028 7601-80029 7601-80033 7601-80034 7601-80035 7601-80036 7601-80037 7601-80038 7601-80039 7601-80043 7601-80045 7601-80047 7601-80049 7601-83535A 7601-83535B 7601-83535C 7601-83535D 7601-83535E 7601-83535F 7601-83535W 7601-90000 7601-90001 7601-90002 7601-90003 7601-90004 7601-90005 7601-90006 7601-90007 7601-90008 7601-90009 7601-90010 7601-90011 7601-90018 7601-90049 7601-90050 7601-90051 7601-90052 7601-90053 7601-90054 7601-90055 7601-90056 7601-90059 7601-90062 7601-90070 7601-90071 7601-90072 7601-90073 7601-90075 7601-90076 7601-90077 7601-90078 7601-90079 7601-90080 7601-90081 7601-90085 7601-90088 7601-90089 7601-90090 7601-90092 7601-90093 7601-90094 7601-90095 7601-90096 7601-90097 7601-90098 7601-90099 7601-90100 7601-90101 7601-90102 7601-90103 7601-90104 7601-90105 7601-90106 7601-90120 7601-90121 7601-90122 7601-90123 7601-90124 7601-90130 7601-90132 7601-90134 7601-90138 7601-90168 7601-90169 7601-90170 7601-90171 7601-90172 7601-90175 7601-90188 7601-90189 7601-90190 7601-90191 7601-90192 7611-540500-55 7611-635100 7611-635110 7611-635120 7611-63550 7611-63570 7611-63580 7611-63590 7611-640215-115 7611-B40240 7611-B40500

About this record

Access comprehensive regulatory information for K2M YUKON OCT Spinal System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502861 and owned by K2M, Inc.. The device was registered on March 12, 2019.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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