510(k) K250769 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
Dakota LP System
| Applicant | Precision Spine, Inc., Pear MS, US |
| Decision | Substantially Equivalent, Nov 24, 2025 |
| Received | Mar 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250769
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.