Scandinavian Total Ankle Replacement (STAR Ankle)
FDA premarket approval P050050/S014 · decided 2020-08-20
Approval details
- PMA number
- P050050
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Scandinavian Total Ankle Replacement (STAR Ankle)
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2020-08-03
- Decision date
- 2020-08-20
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Modification to the gamma sterilization load configuration.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |