INTER FIX THREADED FUSION DEVICE
FDA premarket approval P970015/S028 · decided 2004-07-19
Approval details
- PMA number
- P970015
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTER FIX THREADED FUSION DEVICE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Sofamor Danek
- Date received
- 2004-07-01
- Decision date
- 2004-07-19
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- CHANGE OF STERILIZATION VALIDATION METHODS FOR THE INTER FIX 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 |