PMA P950019S013
- Device
- RAY TFC UNITE PRODUCT LINE
- Applicant
- Stryker Spine
- PMA number
- P950019
- Supplement
- S013
- Product code
- MAX
- Decision date
- 2003-07-15
- Classification
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- APPROVAL FOR NEW MANUFACTURING FACILITIES FOR THE RAY TFC UNITE PRODUCT LINE. THE FACILITIES ARE LOCATED AT CENTERPULSE SPINE-TECH, MINNEAPOLIS, MINNESOTA AND BIOTEST LABORATORIES, INC., MINNEAPOLIS, MINNESOTA.
Current openFDA PMA Record#
- Device
- RAY TFC UNITE PRODUCT LINE
- Applicant
- Stryker Spine
- PMA number
- P950019
- Supplement
- S013
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2003-07-15
- Decision code
- APPR
- Date received
- 2003-02-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR NEW MANUFACTURING FACILITIES FOR THE RAY TFC UNITE PRODUCT LINE. THE FACILITIES ARE LOCATED AT CENTERPULSE SPINE-TECH, MINNEAPOLIS, MINNESOTA AND BIOTEST LABORATORIES, INC., MINNEAPOLIS, MINNESOTA.