510(k) K123485 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
| Applicant | Biomet Sports Medicine, Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 18, 2013 |
| Received | Nov 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Fastener, fixation, nondegradable, soft tissue. Terminated |
MBI | None listed |
| Nov 19, 2013 | Biomet, Inc. Juggerknotless Drill Bit, REF 110003173,
Sterile, Single Use
Product Usage:
The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wr Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.