510(k) K090953 ยท OLO Orthopedic Stereotaxic Instrument
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
| Applicant | Praxim Medivision, SA, La Tronche, FR |
| Decision | Substantially Equivalent, Jan 21, 2010 |
| Received | Apr 3, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2019 | OMNIlife science Inc. OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock C Terminated |
OLO | None listed |
| Nov 17, 2016 | OMNI LIFE SCIENCE OMNIBotics Tracker Kit -Model: RM-10000
The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomic Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.