Pure Global
Singapore HSA registration DE0509698

Brainlab Compatible K2M Navigation Instruments System

Singapore flagSingapore·CLASS B·K2M, Inc.·Registered August 28, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0509698
Registration Date
August 28, 2024
Retention Due Date
August 27, 2025
Product description
The Brainlab Compatible K2M Navigation Instruments are intended for exclusive use with the Brainlab Navigation System to facilitate the preparation and placement of the pedicle screws when implanting Mesa, Denali, Everest and Yukon spinal systems. Indications for use Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of Stryker screws (Mesa, Denali, Everest, and Yukon) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are specifically designed for use with the Brainlab Navigation System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
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
STRYKER SINGAPORE PRIVATE LIMITED
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model information
Model Name(s)
Double Height Case Instrument Case Single Height Case Instrument Case Case Lid EVEREST Polyaxial Screw Inserter Size 3.5mm EVEREST Tapered Tap Size 4.5mm EVEREST Tapered Tap Size 5.5mm EVEREST Tapered Tap Size 6.5mm EVEREST Tapered Tap Size 7.5mm EVEREST Tapered Tap Size 8.5mm EVEREST Tapered Tap EVEREST Locking Screw Inserter EVEREST MI Cannulated Screw Inserter Size 4.0 mm EVEREST MI Cannulated Tap Size 4.5 mm EVEREST MI Cannulated Tap Size 5.5 mm EVEREST MI Cannulated Tap Size 6.5 mm EVEREST MI Cannulated Tap Size 7.5 mm EVEREST MI Cannulated Tap Size 8.5 mm EVEREST MI Cannulated Tap EVEREST XTOWER Locking Screw Inserter MESA 2 Polyaxial Screw Inserter Size 3.5mm MESA 2 Tap Size 4.5mm MESA 2 Tap Size 5.5mm MESA 2 Tap Size 6.5mm MESA 2 Tap Size 7.5mm MESA 2 Tap Size 8.5mm MESA 2 Tap YUKON Polyaxial Screw Inserter Size 3.0mm YUKON Tap Size 3.5mm YUKON Tap Size 4.0mm YUKON Tap Size 4.5mm YUKON Tap Size 5.0mm YUKON Tap Size 2.3 mm YUKON Adjustable Drill Bit Size 2.8 mmYUKON Adjustable Drill Bit Navigation Straight Lumbar Probe Navigation Straight Thoracic Probe Navigation Awl Cervical Navigation Ratcheting Axial Handle Cervical Brainlab Navigation Instrument Tray Thoracolumbar Navigation 1 Instrument Tray Thoracolumbar Navigation 2 Instrument Tray
Model Identifier(s)
2601-90032 2601-90033 2601-90034 2901-N90006-B 2901-N90041-B 2901-N90042-B 2901-N90043-B 2901-N90044-B 2901-N90045-B 2901-N90046-B 2901-N90098-B 5101-N90000-B 5101-N90002-B 5101-N90003-B 5101-N90004-B 5101-N90005-B 5101-N90006-B 5101-N90007-B 5101-N90223-B 6201-N90001-B 6201-N90010-B 6201-N90012-B 6201-N90014-B 6201-N90016-B 6201-N90017-B 6201-N90018-B 7601-N90003-B 7601-N90004-B 7601-N90005-B 7601-N90006-B 7601-N90007-B 7601-N90008-B 7601-N90009-B 7601-N90010-B AB01-N90006-B AB01-N90007-B AB01-N90008-B AB01-N90009-B AB01-N90010-B AB01-N90011-B AB01-N90012-B
About this record

Access comprehensive regulatory information for Brainlab Compatible K2M Navigation Instruments System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509698 and owned by K2M, Inc.. The device was registered on August 28, 2024.

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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