INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE
FDA premarket approval P970015/S017 · decided 2000-12-13
Approval details
- PMA number
- P970015
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Sofamor Danek
- Date received
- 2000-09-28
- Decision date
- 2000-12-13
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE INTERFIX(TM) RP THREADED FUSION DEVICE TO BE ALSO KNOWN AS THE INTERFIX(TM) RP THREADED FUSION DEVICE - REDUCED PROFILE. THE DEVICE WILL NOW BE MARKETED UNDER BOTH TRADE NAMES AND WILL REMAIN INDICATED FOR USE WITH AUTOGENOUS BONE BRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. THE DEVICE IS TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH. DDD I
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM (K991460) | Sofamor Danek | 1999-05-19 |