510(k) K190881 ยท OLO Orthopedic Stereotaxic Instrument
Spinal Elements Navigated Instruments
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 19, 2019 |
| Received | Apr 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190881
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.