510(k) K112507 ยท OLO Orthopedic Stereotaxic Instrument
RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
| Applicant | Mako Surgical Corporation, Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Mar 1, 2012 |
| Received | Aug 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112507
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2018 | Mako Surgical Corporation Stryker Mako Vizadisc Knee Procedure Tracking Kit Terminated |
OLO | None listed |
| Aug 7, 2017 | Mako Surgical Corporation Makoplasty Partial Knee Application (PKA)
Product Usage:
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for o Terminated |
OLO | None listed |
| Jun 7, 2017 | Mako Surgical Corporation MAKO RIO Standard System, internal cPCI Card CageP/N: 201337.
Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures. Terminated |
OLO | None listed |
| Apr 18, 2016 | Mako Surgical Corporation Robotic Arm Interactive Orthopedic System (RIO) Terminated |
OLO | None listed |
| Nov 5, 2015 | Mako Surgical Corporation Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacem Terminated |
OLO | None listed |
| Feb 19, 2015 | Mako Surgical Corporation Restoris Partial Knee Application (PKA) RIO (TGS 2.0).
For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures. Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.