510(k) K123954 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
INFINITY TOTAL ANKLE SYSTEM
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Apr 1, 2013 |
| Received | Dec 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123954
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2024 | Wright Medical Technology, Inc. stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty Open, Classified |
HSN | None listed |
| Jul 7, 2023 | Wright Medical Technology, Inc. Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. Open, Classified |
HSN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.