510(k) K101063 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
SLEEVE WITH ZIPLOOP FIXATION DEVICES
| Applicant | Biomet Sports Medicine, Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 23, 2010 |
| Received | Apr 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2015 | Biomet, Inc. Ziploop Button
Product Usage:
The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease Terminated |
JDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.