510(k) K092381 ยท HRS Plate, Fixation, Bone
IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION
| Applicant | Ibalance Medical, Inc., Philedelphia PA, US |
| Decision | Substantially Equivalent, Oct 27, 2009 |
| Received | Aug 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092381
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.