HSA · registration DE0509698Brainlab Compatible K2M Navigation Instruments System
- Registration number
- DE0509698
- Model name
- 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
- 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
- Registration date
- August 28, 2024
- Risk class
- Class B
- Product owner
- K2M, Inc.
- Registrant / registration holder
- STRYKER SINGAPORE PRIVATE LIMITED
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 address
- 600 Hope Parkway SE, Leesburg, Virginia, 20175, United States
- Registrant address
- 38 BEACH ROAD, #23-11, SOUTH BEACH TOWER, Singapore 189767
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.