510(k) K152217 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Exactech Vantage Total Ankle System
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Mar 10, 2016 |
| Received | Aug 7, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152217
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Exactech, Inc. Exactech Vantage Ankle System, Catalog Numbers:
a) 350-21-04,
b) 350-22-03 Open, Classified |
HSN | None listed |
| Oct 4, 2021 | Exactech, Inc. Vantage Total Ankle System including
a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX);
b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Lin Open, Classified |
HSN | None listed |
| Aug 10, 2020 | Exactech, Inc. The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm. Open, Classified |
HSN | None listed |
| Jul 13, 2018 | Exactech, Inc. Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements. Terminated |
LXH | None listed |
| May 16, 2017 | Exactech, Inc. Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc.,
Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. Terminated |
HSN | None listed |
| May 16, 2017 | Exactech, Inc. Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc.
Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It Terminated |
HSN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.