510(k) K213118 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Dakota ALIF System
| Applicant | Precision Spine, Inc., Pear MS, US |
| Decision | Substantially Equivalent, Apr 1, 2022 |
| Received | Sep 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213118
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.