510(k) K170342 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Ocata Anterior Cervical System
| Applicant | Kalitec Direct, LLC, Orlando FL, US |
| Decision | Substantially Equivalent, May 9, 2017 |
| Received | Feb 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170342
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.