510(k) K960711 ยท KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
ACUMED BONE GRAFT SYSTEM
| Applicant | Acu Med, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent, May 7, 1996 |
| Received | Feb 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960711
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Acumed LLC 6mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 6mm Bone Graft Drill... REF BG-8006-S ... LOT W51258". Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC 10mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 10mm Bone Graft Drill... REF BG-8020-S ... LOT W54076". Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.