Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)
FDA premarket approval P050050/S021 · decided 2022-05-06
Approval details
- PMA number
- P050050
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2022-01-25
- Decision date
- 2022-05-06
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Approval of the post approval study protocol referenced in the Actual Condition of Use Study (STAR 2).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |