510(k) K955729 ยท HRS Plate, Fixation, Bone
LACTOSORB TRAUMA PLATING SYSTEM
| Applicant | Poly-Medics,Inc., Warsaw IN, US |
| Decision | Substantially Equivalent for Some Indications, Feb 14, 1996 |
| Received | Dec 18, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Biomet Microfixation, Inc. Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.