510(k) K203129 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
| Applicant | Precision Spine, Inc., Pear MS, US |
| Decision | Substantially Equivalent, Jan 12, 2021 |
| Received | Oct 19, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203129
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.