510(k) K142230 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Apollo Suture Anchor System and Titan Screws
| Applicant | Valeris Medical, Marietta GA, US |
| Decision | Substantially Equivalent, Sep 10, 2014 |
| Received | Aug 13, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142230
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2018 | Valeris Medical, LLC Apollo XT Suture Anchor, 5.5 x 15
Product Usage:
Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicula Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.