STAR PSI System
FDA premarket approval P050050/S023 · decided 2022-11-22
Approval details
- PMA number
- P050050
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAR PSI System
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2022-04-29
- Decision date
- 2022-11-22
- Days to decision
- 207 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Approval for STAR PSI System, and a new manufacturing facility at Medical Modeling, a 3D Systems Company, 5381 South Alkire Circle, Littleton, CO 80127.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |