510(k) K082172 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
| Applicant | Mako Surgical Corporation, Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Nov 28, 2008 |
| Received | Aug 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082172
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2023 | Howmedica Osteonics Corp. stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure Open, Classified |
HSX | None listed |
| Apr 12, 2023 | Howmedica Osteonics Corp. stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure Open, Classified |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.