510(k) K151312 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
VerteLP Interbody Fusion Device
| Applicant | Vgi, LLC, St. Petersburg FL, US |
| Decision | Substantially Equivalent, Jan 13, 2016 |
| Received | May 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151312
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2018 | VGI Medical, LLC VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit Terminated |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.