510(k) K181596 ยท OLO Orthopedic Stereotaxic Instrument
Spine Wave Navigated Instruments
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Oct 24, 2018 |
| Received | Jun 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181596
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.