510(k) K921480 ยท JDQ Cerclage, Fixation
OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM
| Applicant | Acu-Med, Inc., Beaveton OR, US |
| Decision | Substantially Equivalent, Jun 26, 1992 |
| Received | Mar 30, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921480
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2008 | Acumed LLC Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 9712 Terminated |
JDQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.