PMA P950019S016
- Device
- RAY TFC UNITE
- Applicant
- Stryker Spine
- PMA number
- P950019
- Supplement
- S016
- Product code
- MAX
- Decision date
- 2003-10-10
- Classification
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- APPROVAL FOR LABELING CHANGES (CHANGE OF ADDRESS, CHANGE IN CE MARK, ADDITIONAL PATENT STATEMENT) AND CHANGES IN PART NUMBERS.
Current openFDA PMA Record#
- Device
- RAY TFC UNITE
- Applicant
- Stryker Spine
- PMA number
- P950019
- Supplement
- S016
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2003-10-10
- Decision code
- APPR
- Date received
- 2003-09-26
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES (CHANGE OF ADDRESS, CHANGE IN CE MARK, ADDITIONAL PATENT STATEMENT) AND CHANGES IN PART NUMBERS.