Scandinavian Total Ankle Replacement (STAR Ankle)
FDA premarket approval P050050/S015 · decided 2020-12-01
Approval details
- PMA number
- P050050
- Supplement
- S015
- 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
- 2020-11-02
- Decision date
- 2020-12-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Modification to the gamma sterilization load configuration, positioning in the sterilization chamber and subsequent dose map validation.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |