SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R. ANKLE)
FDA premarket approval P050050/S010 · decided 2016-09-28
Approval details
- PMA number
- P050050
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R. ANKLE)
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2016-07-12
- Decision date
- 2016-09-28
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Approval for the use of three specific saw blades in the S.T.A.R. ankle surgical technique.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |