510(k) K143752 ยท OLO Orthopedic Stereotaxic Instrument
Total Knee Application (TKA)
| Applicant | Mako Surgical Corp., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Aug 6, 2015 |
| Received | Dec 31, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143752
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2019 | Mako Surgical Corporation 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) Terminated |
OLO | None listed |
| Apr 25, 2019 | Mako Surgical Corporation 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0) Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.