LUMBAR I/F CAGE WITH VSP SPINE SYSTEM
FDA premarket approval P960025/S005 · decided 2000-09-08
Approval details
- PMA number
- P960025
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUMBAR I/F CAGE WITH VSP SPINE SYSTEM
- Generic name
- SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
- Applicant
- Depuy Spine, Inc.
- Date received
- 2000-06-06
- Decision date
- 2000-09-08
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- MCV
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raynham, MA
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CONFIDENCE Spinal Cement System (K201831) | Depuy Spine, Inc. | 2020-08-31 |
| EXPEDIUM VERSE SPINE SYSTEM (K142185) | Depuy Spine, Inc. | 2014-11-19 |
| EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (K111136) | Depuy Spine, Inc. | 2012-06-14 |
| VIPER SYSTEM (K121020) | Depuy Spine, Inc. | 2012-05-03 |
| MOUNTAINEER OCT SPINAL SYSTEM (K110353) | Depuy Spine, Inc. | 2011-04-07 |
| EXPEDIUM SYSTEM, VIPER SYSTEM (K110216) | Depuy Spine, Inc. | 2011-04-01 |
| VEPER SYSTEM, EXPEDIUM SYSTEM (K103133) | Depuy Spine, Inc. | 2011-01-18 |
| VIPER SYSTEM, EXPEDIUM SYSTEM (K101993) | Depuy Spine, Inc. | 2010-12-07 |