510(k) K121936 ยท OLO Orthopedic Stereotaxic Instrument
NAVIOPFS
| Applicant | Blue Belt Technologies, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Nov 30, 2012 |
| Received | Jul 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121936
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2020 | Smith & Nephew, Inc. NAVIO Soft Tissue Protector, included in instrument kits.
The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navi Terminated |
OLO | None listed |
| May 9, 2014 | Blue Belt Technologies MN NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020. Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.