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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2016 | K161597 | Tyber Medical BioTy® Nanotopography Trauma Screw Tyber Medical, LLC | HWC |
| Nov 15, 2016 | K160791 | AmorChem Titanium Porous Fixation Device Amorchem Holdings, Inc., CA | HWC |
| Oct 11, 2016 | K161449 | HammerTech Fixation System Fusion Orthopedics, LLC | HWC |
| Oct 6, 2016 | K160174 | I.B.S. 2.0 Osteosynthesis screw In2bones Sas, FR | HWC |
| Aug 1, 2016 | K153065 | The Hammertoe Correction System Life Spine, Inc. | HWC |
| Jul 29, 2016 | K161058 | Cannulated Screw Miami Device Solutions, LLC | HWC |
| Jun 30, 2016 | K161539 | Arthrosurface Bone Screws Arthrosurface, Inc. | HWC |
| Jun 23, 2016 | K160169 | The Life Spine Subtalar Implant System Life Spine | HWC |
| Jun 3, 2016 | K160617 | Large Screws Range Newclip Technics, FR | HWC |
| Jun 3, 2016 | K160427 | dynaMX(TM) Nitinol Compression Screw Mx Orthopedics, Corp. | HWC |
| Apr 29, 2016 | K160548 | MC-Subtalar(TM) II Merete Medical GmbH, DE | HWC |
| Apr 29, 2016 | K160304 | OsteoBullet Compression Screw Phalanx Innovations | HWC |
| Apr 19, 2016 | K153638 | Bicortical Fixation Screw & Washer Nut System First Ray, LLC | HWC |
| Mar 28, 2016 | K160603 | SMV Scientific Schanz Screws Smv Scientific | HWC |
| Mar 9, 2016 | K160058 | Biomet Variable Pitch Compression Screw System Biomet, Inc. | HWC |
| Mar 2, 2016 | K151708 | RECON system - Compression Screws Normed Medizin-Technik GmbH, DE | HWC |
| Feb 26, 2016 | K153575 | Tyber Medical Trauma Screw Tyber Medical, LLC | HWC |
| Feb 25, 2016 | K153759 | SIGN Compression Screw System Sign Fracture Care International | HWC |
| Feb 12, 2016 | K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Scre Merete Medical GmbH, DE | HWC |
| Feb 5, 2016 | K143596 | MINIARS SCREWS Overmed Srl., IT | HWC |
| Jan 26, 2016 | K151701 | Tenodesis screw system Normed Medizin-Technik GmbH, DE | HWC |
| Jan 19, 2016 | K153333 | Epic Extremity Cannulated Screw System Epic Extremity, LLC | HWC |
| Jan 14, 2016 | K153338 | Tiger Cannulated Screw System Trilliant Surgical, Ltd. | HWC |
| Dec 28, 2015 | K153154 | Asnis JFX System Stryker Trauma AG | HWC |
| Dec 21, 2015 | K153378 | Monster BITE Screw System Paragon 28 | HWC |
| Nov 25, 2015 | K153182 | SELF- COMPRESSIVE SCREW Neosteo, FR | HWC |
| Nov 25, 2015 | K153180 | Tyber Medical MST Trauma Screw Tyber Medical, LLC | HWC |
| Nov 24, 2015 | K152841 | Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws Zimmer, Inc. | HWC |
| Nov 10, 2015 | K150211 | EzFuze Implant System Vilex IN Tennessee, Inc. | HWC |
| Oct 29, 2015 | K152527 | Integra DigiFuse Cannulated Intramedullary Fusion System Ascension Orthopedics | HWC |
| Oct 15, 2015 | K152710 | HammerFiX Device Extremity Medical, LLC | HWC |
| Oct 13, 2015 | K150693 | PHIN-FX Cannulated Lag Screw System Ascent Medical, LLC | HWC |
| Sep 23, 2015 | K152072 | CrossRoads Screw System Crossroads Extremity Systems, LLC | HWC |
| Sep 4, 2015 | K151838 | PRO-TOE Hammertoe Fixation System Wrightmedicaltechnologyinc | HWC |
| Sep 4, 2015 | K151270 | CrossTIE Intraosseous Fixation System Crossroads Extremity Systems, LLC | HWC |
| Aug 7, 2015 | K151241 | Synchro-Medical TIGER TRACK Screw System Synchro Medical, FR | HWC |
| Aug 4, 2015 | K150871 | ForeFoot STP System Tornier, Inc. | HWC |
| Jul 24, 2015 | K151146 | N-Force Fixation System Innovision, Inc. | HWC |
| Jul 15, 2015 | K151418 | Monster Screw System Paragon 28 | HWC |
| Jul 15, 2015 | K151021 | OsteoMed Cannulated Screw System Osteomed Corp. | HWC |
| Jun 23, 2015 | K150981 | SMV Scientific Bone Screws Smv Scientific | HWC |
| Jun 12, 2015 | K150376 | Sonoma Cancellous Bone Screw and Washer Sonoma Orthopedics Products, Inc. | HWC |
| Jun 4, 2015 | K150443 | ToeTac Hammertoe Fixation System Restore Surgical, LLC Dba Instratek | HWC |
| May 26, 2015 | K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation | HWC |
| May 15, 2015 | K151078 | Arthrex RetroFusion Screw Arthrex, Inc. | HWC |
| May 11, 2015 | K150126 | Life Spine Cannulated Screws Life Spine, Inc. | HWC |
| May 8, 2015 | K150772 | Snap-Off Self-Compressive Screw Neosteo, FR | HWC |
| May 8, 2015 | K150213 | Subtalar Spacer System (STS) Wrightmedicaltechnologyinc | HWC |
| Apr 29, 2015 | K150974 | aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium Aap Implantate AG, DE | HWC |
| Apr 29, 2015 | K150252 | PHALINX Hammertoe System Wrightmedicaltechnologyinc | HWC |
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