510(k) K141989 ยท OLO Orthopedic Stereotaxic Instrument
MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
| Applicant | Mako Surgical Corporation, Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Nov 13, 2014 |
| Received | Jul 22, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141989
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2020 | Mako Surgical Corporation Mako Hip End Effector, Variable Angle
Catalog Number: 206967
GTIN:00848486022167 Terminated |
OLO | None listed |
| Aug 7, 2017 | Mako Surgical Corporation Total Hip Application (THA)
Product Usage:
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation an Terminated |
OLO | None listed |
| Dec 22, 2016 | Mako Surgical Corporation MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery. Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.