Scandinavian Total Ankle Replacement (STAR)
FDA premarket approval P050050/S026 · decided 2024-03-13
Approval details
- PMA number
- P050050
- Supplement
- S026
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Scandinavian Total Ankle Replacement (STAR)
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2023-12-13
- Decision date
- 2024-03-13
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P050050/S024 (Scandinavian Total Ankle Replacement System).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |