PMA P960025S004
- Device
- LUMBAR I/F CAGE WITH VSP SPINE SYSTEM
- Applicant
- Depuy Spine, Inc.
- PMA number
- P960025
- Supplement
- S004
- Product code
- MCV
- Decision date
- 2001-01-12
- Classification
- Spinal Pedicle Screw, Fixation, Appliance System
- Generic name
- SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
- Approval order statement
- APPROVAL FOR THE USE OF THE LUMBAR I/F CAGE COMPONENT OF THE LUMBAR I/F CAGE(R) WITH VSP(R) SPINE SYSTEM WITH ADDITIONAL PEDICLE SCREW SPINAL SYSTEMS. SPECIFICALLY, FOR USE WITH THE FOLLOWING SIX ADDITIONAL POSTERIOR PEDICLE SCREW SPINAL SYSTEMS: 1) THE TI ALLOY VERSION OF THE VSP SPINE SYSTEM; 2) TI ALLOY AND STAINLESS STEEL VERSIONS OF THE ISOLA SPINE SYSTEM; 3) TIMX SPINE SYSTEM; AND 4) THE TI ALLOY AND STAINLESS STEEL VERSIONS OF THE MOSS MIAMI SPINE SYSTEM. IN ADDITION, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMBAR I/F CAGE SYSTEM. THE INDICATION FOR THESE IMPLANTS HAS NOT BEEN CHANGED FROM THAT APPROVED ON FEBRUARY 2, 1999.
Current openFDA PMA Record#
- Device
- LUMBAR I/F CAGE WITH VSP SPINE SYSTEM
- Applicant
- Depuy Spine, Inc.
- PMA number
- P960025
- Supplement
- S004
- Product code
- MCV
- Generic name
- SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
- Decision date
- 2001-01-12
- Decision code
- APPR
- Date received
- 2000-04-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF THE LUMBAR I/F CAGE COMPONENT OF THE LUMBAR I/F CAGE(R) WITH VSP(R) SPINE SYSTEM WITH ADDITIONAL PEDICLE SCREW SPINAL SYSTEMS. SPECIFICALLY, FOR USE WITH THE FOLLOWING SIX ADDITIONAL POSTERIOR PEDICLE SCREW SPINAL SYSTEMS: 1) THE TI ALLOY VERSION OF THE VSP SPINE SYSTEM; 2) TI ALLOY AND STAINLESS STEEL VERSIONS OF THE ISOLA SPINE SYSTEM; 3) TIMX SPINE SYSTEM; AND 4) THE TI ALLOY AND STAINLESS STEEL VERSIONS OF THE MOSS MIAMI SPINE SYSTEM. IN ADDITION, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMBAR I/F CAGE SYSTEM. THE INDICATION FOR THESE IMPLANTS HAS NOT BEEN CHANGED FROM THAT APPROVED ON FEBRUARY 2, 1999.