510(k) K211111 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
SureMAX-SA Cervical Standalone System
| Applicant | Additive Implants, Inc., Phoenix AZ, US |
| Decision | Substantially Equivalent, Jul 16, 2021 |
| Received | Apr 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211111
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.