LUMBAR I/F CAGE SYSTEM
FDA premarket approval P960025/S006 · decided 2001-05-14
Approval details
- PMA number
- P960025
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- LUMBAR I/F CAGE SYSTEM
- Generic name
- SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
- Applicant
- Depuy Spine, Inc.
- Date received
- 2001-03-27
- Decision date
- 2001-05-14
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MCV
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raynham, MA
- Statement
- APPROVAL FOR THE FOLLOWING FOUR CHANGES TO THE INVESTIGATIONAL PLAN (IP) FOR THE POSTAPPROVAL STUDY: 1) THE USE OF ADDITIONAL PEDICLE SCREW SPINAL SYSTEMS WITH THE I/F CAGE COMPONENT, I.E., TO ALLOW FOR TH EUSE OF THE TI ALLOY VERSION OF THE VSP SPINE SYSTEM, THE TI ALLOY AND STAINLESS STEEL VERSIONS OF THE ISOLA SPINE SYSTEM, THE TIMX SPINE SYSTEM AND THE TI ALLOY AND STAINLESS STEEL VERSIONS OF THE MOSS MIAMI SPINE SYSTEM IN ADDITION TO THE STAINLESS STEEL VERSION OF THE VSP SPINE SYSTEM; 2) A
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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 |