Panels › Orthopedic › Product code HWC · Class 2
Screw, Fixation, Bone
Regulation 888.3040
22510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
Top companies in HWC
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 12 | 50 |
| Biomet, Inc. | 24 | 27 |
| Arthrex, Inc. | 47 | 1 |
| Acumed, LLC | 5 | 35 |
| Depuy Mitek, A Johnson & Johnson Co. | 13 | 21 |
| Synthes (Usa) | 31 | 3 |
| Smith & Nephew, Inc. | 27 | 6 |
| Smith & Nephew Inc., Endoscopy Division | 1 | 30 |
| Wrightmedicaltechnologyinc | 31 | 0 |
| Stryker Howmedica Osteonics Corp. | 0 | 30 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K012655 |
| 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 | K012655 |
| 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 | K960711 |
| 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 | K960711 |
| 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 | K033639 |
| 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 | K033639 |
| 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 | K033639 |
| 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 | K033639 |
| 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 | K033639 |
| 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 | K033639 |
| 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 | K033639 |
| 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 | K033639 |
| 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 | K033639 |
| 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 | K033639 |
| 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 | K012655 K942340 +1 |
| Aug 28, 2008 | Acumed LLC 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed Terminated |
HWC | K942340 |
| Aug 15, 2008 | Integra LifeSciences Corp. QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction. Terminated |
HWC | K050346 |
| Aug 15, 2008 | Integra LifeSciences Corp. QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction. Terminated |
HWC | K050346 |
| Aug 6, 2008 | Stryker Endoscopy Stryker Peek Intraline Anchor, 6.5 mm with Needles, Model number 3910-400-025
Used for tissue fixation to bone in certain areas. Terminated |
HWC | K071157 |
| Aug 6, 2008 | Stryker Endoscopy Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020
Used for tissue fixation to bone in certain areas. Terminated |
HWC | K071157 |
| Aug 6, 2008 | Stryker Endoscopy Stryker Peek Intraline Anchor, 5.5 mm with Needles, Model number 3910-400-015
Used for tissue fixation to bone in certain areas. Terminated |
HWC | K071157 |
| Aug 6, 2008 | Stryker Endoscopy Stryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010
Used for tissue fixation to bone in certain areas. Terminated |
HWC | K071157 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 8 mm x 25 mm,
P/N 72201073, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 25 mm,
P/N 72201072, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 20 mm,
P/N 72201071, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 20 mm,
P/N 72201070, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 20 mm,
P/N 72201069, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 12 mm x 35 mm,
P/N 7211127, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 35 mm,
P/N 7211126, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 30 mm,
P/N 7211125, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm,
P/N 7211124, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 30 mm,
P/N 7211123, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 25 mm,
P/N 7211122, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 35 mm,
P/N 7211121, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 30 mm,
P/N 7211120, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 25 mm,
P/N 7211119, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm,
P/N 7211118, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 30 mm,
P/N 7211117, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 25 mm,
P/N 7211116, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 30 mm,
P/N 7211115, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 7 mm x 25 mm,
P/N 7211114, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm,
P/N 7211113, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 20 mm,
P/N 7211112, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 6 mm x 25 mm,
P/N 7211111, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 25 mm,
P/N 7211110, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm,
P/N 7211109, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | K051310 |
| Nov 2, 2006 | DePuy Spine, Inc. HI Fix Skull Pins, DePuy Spine Bremer Halo System
Product Code: AC020 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Extra Long Skull Pins, DePuy Spine Bremer Halo System
Product Number: AC018 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Skull pins w/Torque, DePuy Spine Bremer Halo System
Product Code: AC014 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Standard Skull Rings, DePuy Spine Bremer Halo System
Product Code: AC007 Terminated |
HWC | K915800 K993099 |
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