NOVUS (TM) LC INTERBODY FUSION DEVICE
FDA premarket approval P970015/S001 · decided 1999-05-14
Approval details
- PMA number
- P970015
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVUS (TM) LC INTERBODY FUSION DEVICE
- Applicant
- Sofamor Danek
- Date received
- 1998-06-15
- Decision date
- 1999-05-14
- Days to decision
- 333 days
- Decision code
- APPR
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Supplement received prior to original approval. This supplement was approved as part of the original approval order.
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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 |