510(k) K120906 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
ZIMMER TRABECULAR METAL TOTAL ANKLE
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 24, 2012 |
| Received | Mar 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120906
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. TM Ankle and Ankle Talus L/R, Item Nos. 00450001100
00450001200
00450001300
00450001400
00450001500
00450001600
00450002100
00450002200
00450002300
00450002400
00450002500
00450002600 Terminated |
HSN | None listed |
| Dec 10, 2013 | Zimmer, Inc. Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6
Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving Terminated |
HSN | None listed |
| Dec 10, 2013 | Zimmer, Inc. Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6
Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preservin Terminated |
HSN | None listed |
| Dec 10, 2013 | Zimmer, Inc. Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6
Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preservi Terminated |
HSN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.