PMA P960025S005
- Device
- LUMBAR I/F CAGE WITH VSP SPINE SYSTEM
- Applicant
- Depuy Spine, Inc.
- PMA number
- P960025
- Supplement
- S005
- Product code
- MCV
- Decision date
- 2000-09-08
- Classification
- Spinal Pedicle Screw, Fixation, Appliance System
- Generic name
- SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
- Approval order statement
- APPROVAL FOR CHANGING THE MATERIAL OF THE I/F CAGE DEVICE COMPONENT FROM INJECTION MOLDED PEKEKK WITH CHOPPED CARBON FIBERS IN A FIBER:MATRIX RATIO OF 30:70 TO INJECTION MOLDED PEEK WITH CHOPPED CARBON FIBERS IN A FIBER:MATRIX RATIO OF 30:70.
Current openFDA PMA Record#
- Device
- LUMBAR I/F CAGE WITH VSP SPINE SYSTEM
- Applicant
- Depuy Spine, Inc.
- PMA number
- P960025
- Supplement
- S005
- Product code
- MCV
- Generic name
- SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
- Decision date
- 2000-09-08
- Decision code
- APPR
- Date received
- 2000-06-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGING THE MATERIAL OF THE I/F CAGE DEVICE COMPONENT FROM INJECTION MOLDED PEKEKK WITH CHOPPED CARBON FIBERS IN A FIBER:MATRIX RATIO OF 30:70 TO INJECTION MOLDED PEEK WITH CHOPPED CARBON FIBERS IN A FIBER:MATRIX RATIO OF 30:70.