510(k) K130703 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
VIVORTE BVF
| Applicant | Vivorte, Inc., Fort Wayne IN, US |
| Decision | Substantially Equivalent, Sep 12, 2013 |
| Received | Mar 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130703
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2021 | Vivorte, Inc. Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system
Model Number: 130703-10 Terminated |
MBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.