INTER FIX RP THREADED FUSION DEVICE
FDA premarket approval P970015/S009 · decided 2000-04-12
Approval details
- PMA number
- P970015
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTER FIX RP THREADED FUSION DEVICE
- Applicant
- Sofamor Danek
- Date received
- 1999-10-07
- Decision date
- 2000-04-12
- Days to decision
- 188 days
- Decision code
- APPR
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for the 22 and 24 mm Diameter Inter Fix RP Threaded Fusion Device.
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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 |