510(k) K080822 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
VU APOD INTERVERTABRAL BODY FUSION DEVICE
| Applicant | Theken Spine, LLC, Akron OH, US |
| Decision | Substantially Equivalent, Jul 2, 2008 |
| Received | Mar 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080822
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2011 | Integra LifeSciences Corp. Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as individual instruments and implants in poly b Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.