510(k) K102323 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
| Applicant | Theken Spine, LLC, Akron OH, US |
| Decision | Substantially Equivalent, Dec 16, 2010 |
| Received | Aug 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102323
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.