PMA P950019S010
- Device
- RAY THREADED FUSION CAGE(TFC)
- Applicant
- Stryker Spine
- PMA number
- P950019
- Supplement
- S010
- Product code
- MAX
- Decision date
- 1999-12-01
- Classification
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- Approval for the Sulzer Spine-Tech facility located at 8990 Springbrook Drive, #10, Minneapolis, Minnesota 55433 as an alternate site for assembly, packaging and quality control of the device and the BioTest Laboratories, Inc., located at 7375 Bush Lake Rd., Minneapolis, Minnesota 55439 as an alternate site for assembly, packaging and labeling of the device.
Current openFDA PMA Record#
- Device
- RAY THREADED FUSION CAGE(TFC)
- Applicant
- Stryker Spine
- PMA number
- P950019
- Supplement
- S010
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 1999-12-01
- Decision code
- APPR
- Date received
- 1999-09-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- Approval for the Sulzer Spine-Tech facility located at 8990 Springbrook Drive, #10, Minneapolis, Minnesota 55433 as an alternate site for assembly, packaging and quality control of the device and the BioTest Laboratories, Inc., located at 7375 Bush Lake Rd., Minneapolis, Minnesota 55439 as an alternate site for assembly, packaging and labeling of the device.