510(k) K012655 ยท HRS Plate, Fixation, Bone
CONGRUENT BONE PLATE SYSTEM
| Applicant | Acu Med, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent, Nov 7, 2001 |
| Received | Aug 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012655
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2010 | Acumed LLC Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, U Terminated |
HRS | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 10 Holes Large Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 10 Holes Large Left... REF PL-CL10L Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 10 Holes Large Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 10 Holes Large Right... REF PL-CL1 Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 6 Holes Small Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 6 Holes Small Left ... REF PL-CL6SL- Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 6 Holes Small Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 6 Holes Small Right ... REF PL-CL6S Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes, J-Plate Left... REF PL-C Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes, J-Plate Right... REF PL Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Large Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Large Left ... REF PL-CL8LL- Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Large Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Large Right ... REF PL-CL8L Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Medium Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Medium Left ... REF PL-CL8M Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Medium Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Medium Right ... REF PL-CL Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Small Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Small Right ... REF PL-CL8S Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 9 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 9 Holes, J-Plate Left... REF PL-C Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 9 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 9 Holes, J-Plate Right... REF PL Terminated |
HWC | None listed |
| Sep 11, 2008 | Acumed LLC Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System Terminated |
HWC | None listed |
| Aug 28, 2008 | Acumed LLC Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ". Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.