510(k) K111471 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
| Applicant | Medshape Solutions, Inc., Atlanta GA, US |
| Decision | Substantially Equivalent, Jun 10, 2011 |
| Received | May 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2013 | Medshape Solutions, INC. ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230.
For use in the fixation of ligaments, tendons or soft tissue grafts to bone. Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.