510(k) K170891 ยท OLO Orthopedic Stereotaxic Instrument
Mako Partial Knee Application
| Applicant | Mako Surgical Corp., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, May 24, 2017 |
| Received | Mar 27, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170891
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Mako Surgical Corporation Rio System Irrigation Clip - Catalog # 111690
Product Usage:
The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the sur Terminated |
OLO | None listed |
| Dec 27, 2017 | Mako Surgical Corporation Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933
Product Usage:
The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical kn Terminated |
OLO | None listed |
| Dec 1, 2017 | Mako Surgical Corporation RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements. Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.