510(k) K160385 ยท OLO Orthopedic Stereotaxic Instrument
Precision Screw
| Applicant | Cryptych Pty, Ltd., North Sydney, AU |
| Decision | Substantially Equivalent, Jul 27, 2016 |
| Received | Feb 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160385
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.