510(k) K033639 ยท HWC Screw, Fixation, Bone
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
| Applicant | Acumed, LLC, Hillsboro OR, US |
| Decision | Substantially Equivalent, Jan 15, 2004 |
| Received | Nov 20, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033639
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Acumed LLC 5 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 5 Hole Locking 1st Tarsometatarsal Plate... REF 70-0007-S... Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC 4 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 4 Hole Locking 1st Tarsometatarsal Plate... REF 70-0008-S... L Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC 4 Hole Locking 2nd and 3rd Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 4 Hole Locking 2nd and 3rd Tarsometatarsal Plate... R Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Left Locking Proximal Metatarsal Wedge Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Proximal Metatarsal Wedge Plate... REF 70-001 Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Right Locking Proximal Metatarsal Wedge Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking Proximal Metatarsal Wedge Plate... REF 70-0 Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Left Locking Dorsal 1st MTP Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Dorsal 1st MTP Fusion Plate... REF 70-0012-S... L Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Left Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 1st MTP Revision Fusion Plate... REF 70-0018-S. Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Right Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP Revision Fusion Plate... REF 70-0019- Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 2st MTP/MPJ Combo Fusion Plate... REF 70-0036- Terminated |
HWC | None listed |
| Sep 20, 2008 | Acumed LLC Right Locking 1st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP/MPJ Combo Fusion Plate... REF 70-003 Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.