510(k) K110054 ยท OLO Orthopedic Stereotaxic Instrument
NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
| Applicant | Zimmer Cas, Montreal, CA |
| Decision | Substantially Equivalent, Mar 24, 2011 |
| Received | Jan 7, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110054
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2022 | Orthosoft, Inc. dba Zimmer CAS NavitrackER Kit A: Knee, Model Number 20-8000-000-07, Open, Classified |
OLO | None listed |
| Apr 26, 2017 | Orthosoft, Inc. dba Zimmer CAS Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument
CAS Software application intended to assist in the placement of total knee replacement components Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.