510(k) K133036 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
| Applicant | Amendia, Inc., Fr. Myers FL, US |
| Decision | Substantially Equivalent, Mar 6, 2014 |
| Received | Sep 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2018 | Valeris Medical, LLC Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, S Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.