510(k) K093425 ยท OLO Orthopedic Stereotaxic Instrument
MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA
| Applicant | Mako Surgical Corp., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Feb 24, 2010 |
| Received | Nov 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2024 | Howmedica Osteonics Corp. MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 Open, Classified |
OLO | None listed |
| Nov 1, 2011 | Mako Surgical Corporation Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9 Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.