INTER FIX TM THREADED FUSION DEVICE
FDA premarket approval P970015/S031 · decided 2005-07-27
Approval details
- PMA number
- P970015
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Other
- Trade name
- INTER FIX TM THREADED FUSION DEVICE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Sofamor Danek
- Date received
- 2005-01-28
- Decision date
- 2005-07-27
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE POST APPROVAL STUDY. THE DEVICE REMAINS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. INTER FIX IMPLANTS AND INTER FIX RP IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE G
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM (K991460) | Sofamor Danek | 1999-05-19 |