510(k) K143547 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Vivorte Trabexus EB
| Applicant | Vivorte, Inc., Louisville KY, US |
| Decision | Substantially Equivalent, Jan 14, 2015 |
| Received | Dec 15, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143547
| 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.