510(k) K133785 ยท JDQ Cerclage, Fixation
TRITIUM STERNAL CABLE PLATE SYSTEM
| Applicant | Pioneer Surgical Technology, Inc., Marquette MI, US |
| Decision | Substantially Equivalent, Jan 27, 2014 |
| Received | Dec 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133785
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2014 | PIONEER SURGICAL TECHNOLOGY, INC. Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile.
The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall incl Terminated |
JDQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.