SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM
FDA premarket approval P050050/S002 · decided 2010-12-27
Approval details
- PMA number
- P050050
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2009-08-21
- Decision date
- 2010-12-27
- Days to decision
- 493 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |