SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)
FDA premarket approval P050050/S005 · decided 2013-01-24
Approval details
- PMA number
- P050050
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Djo Global
- Date received
- 2012-11-13
- Decision date
- 2013-01-24
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Austin, TX
- Statement
- APPROVAL FOR A REVISED PACKAGE INSERT WHICH INCLUDES ADDITIONAL POTENTIAL ADVERSE EVENTS REPORTED IN RECENT STAR ANKLE PUBLICATIONS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RSP HUMERAL SOCKET INSERT (K141006) | Djo Global | 2014-06-05 |