510(k) K965029 ยท JEC Component, Traction, Invasive
STABLELOC II EXTERNAL FIXATOR
| Applicant | Acu Med, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent, Feb 19, 1997 |
| Received | Dec 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965029
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2010 | Acumed LLC Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed Terminated |
JEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.