S.T.A.R Ankle System
FDA premarket approval P050050/S012 · decided 2019-10-21
Approval details
- PMA number
- P050050
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- S.T.A.R Ankle System
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2018-08-21
- Decision date
- 2019-10-21
- Days to decision
- 426 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Approval for a change in sealing to the packaging for the existing STAR implants.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |