FDA Product Code
FDA Product Code HWC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 1,069 records · page 3 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K180932 | Diamond Orthopedic Bone Fixation Screws and Pins | Diamond Orthopedic, LLC | 2018-05-09 | Special | PDF ↗ |
| K180257 | InCore® Lapidus System | Nextremity Solutions, Inc. | 2018-04-25 | Traditional | PDF ↗ |
| K180753 | SafetyFix EasyOut System | Safetyfix Medical Technologies, Inc. | 2018-04-20 | Special | PDF ↗ |
| K173710 | MotoBAND CP Implant System | Crossroads Extremity Systems, LLC | 2018-02-12 | Special | PDF ↗ |
| K172698 | G-Beam Fusion Beaming System | Orthofix Srl | 2018-02-07 | Traditional | PDF ↗ |
| K171628 | HBS2 Headless Bone Screw | Stuckenbrock Medizintechnik GmbH | 2018-01-12 | Traditional | PDF ↗ |
| K172383 | Arthrosurface Bone Screws | Arthrosurface, Inc. | 2017-12-22 | Traditional | PDF ↗ |
| K173286 | Cannulated Screw Internal Fixation System | Life Spine, Inc. | 2017-12-14 | Traditional | PDF ↗ |
| K170688 | PITStop® implant | In2bones Sas | 2017-11-28 | Traditional | PDF ↗ |
| K173135 | VariAx 2 System | Stryker GmbH | 2017-11-27 | Traditional | PDF ↗ |
| K172617 | Treace Medical Concepts (TMC) Compression Screw System | Treace Medical Concepts, Inc. | 2017-10-25 | Traditional | PDF ↗ |
| K172213 | MECRON Cannulated Screw System | Merete GmbH | 2017-10-23 | Traditional | PDF ↗ |
| K170056 | IRENE Cannulated Screw System | Tianjin Zhengtian Medical Instrument Co., Ltd. | 2017-10-23 | Traditional | PDF ↗ |
| K172596 | Large Screws Range | Newclip Technics | 2017-10-02 | Special | PDF ↗ |
| K163148 | BePOD® Foot Screws | Fournitures Hospitalieres Industrie | 2017-09-14 | Traditional | PDF ↗ |
| K163710 | BePOD® EZ Weil Screws | Fournitures Hospitalieres Industrie | 2017-09-08 | Traditional | PDF ↗ |
| K162171 | S4 Screw System | Subchondral Solutions | 2017-09-07 | Traditional | PDF ↗ |
| K171558 | ExsoMed ITN Cannulated Screw System | Exsomed Holdings Company, LLC | 2017-09-01 | Traditional | PDF ↗ |
| K171407 | ExsoMed ArcPhix and ExsoMed ArrowPhix | Exsomed Holding Company, LLC | 2017-08-18 | Traditional | PDF ↗ |
| K170782 | Medline UNITE® Snap-Off Screws | Medline Industries, Inc. | 2017-08-18 | Special | PDF ↗ |
| K170624 | TalarLift STS | Fusion Orthopedics, LLC | 2017-08-11 | Traditional | PDF ↗ |
| K170038 | FuzeFix Screw System | Fusion Orthopedics, LLC | 2017-08-07 | Traditional | PDF ↗ |
| K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System | Ascension Orthopedics | 2017-07-14 | Traditional | PDF ↗ |
| K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | Extremity Medical, LLC | 2017-07-13 | Traditional | PDF ↗ |
| K171448 | Hammertoe Correction System | Life Spine, Inc. | 2017-07-07 | Traditional | PDF ↗ |
| K162874 | Cannulated Screws Neoortho | Neoortho Produtos Ortopedicos S/A | 2017-06-27 | Traditional | PDF ↗ |
| K170571 | Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw | Tyber Medical, LLC | 2017-06-20 | Traditional | PDF ↗ |
| K162685 | 2-Piece Hammertoe Correction System | Life Spine, Inc. | 2017-06-09 | Traditional | PDF ↗ |
| K170687 | Flower Bone Screw Set | Flower Orthopedics Corporation | 2017-06-06 | Special | PDF ↗ |
| K170698 | ALLY(TM) Bone Screws | Providence Medical Technology, Inc. | 2017-05-31 | Traditional | PDF ↗ |
| K170021 | SMV Scientific Cannulated Screws | Smv Scientific | 2017-05-22 | Traditional | PDF ↗ |
| K170382 | Arthrex Compression Screws | Arthrex, Inc. | 2017-05-11 | Special | PDF ↗ |
| K170594 | I.B.S. osteosynthesis screws | In2bones Sas | 2017-05-10 | Special | PDF ↗ |
| K162825 | CAPTIVATE Compression Screws | Globus Medical, Inc. | 2017-05-01 | Traditional | PDF ↗ |
| K170889 | HV Screw System | Wrightmedicaltechnologyinc | 2017-04-26 | Traditional | PDF ↗ |
| K170012 | Foot and Hand Motion | Newclip Technics | 2017-04-24 | Traditional | PDF ↗ |
| K162353 | MICATM Screw System | Wrightmedicaltechnologyinc | 2017-04-13 | Traditional | PDF ↗ |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw System | Osteomed, LLC | 2017-04-04 | Traditional | PDF ↗ |
| K170040 | BePOD Cannulated Arthrodesis Screws | Fournitures Hospitalieres Industrie | 2017-04-04 | Traditional | PDF ↗ |
| K163489 | OrthoSolutions 'System26' Bone Screws | Ortho Solutions UK Limited | 2017-03-08 | Traditional | PDF ↗ |
| K170350 | ToeMATE® Hammertoe Correction System | Arthrosurface, Inc. | 2017-03-03 | Special | PDF ↗ |
| K163038 | EPIC Extremity Snap-Off Screw | Epic Extremity, LLC | 2017-02-28 | Traditional | PDF ↗ |
| K161894 | SurgTech Trauma System | Surgtech, Inc. | 2017-02-21 | Traditional | PDF ↗ |
| K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw | Synthes USA Products, LLC | 2017-02-16 | Traditional | PDF ↗ |
| K161334 | RASL Repair Kit | Radicle Orthopaedics, Inc. | 2017-02-09 | Traditional | PDF ↗ |
| K161904 | GEO Bone Screw System | Gramercy Extremity Orthopeidics, LLC | 2017-01-18 | Traditional | PDF ↗ |
| K161259 | KLS Martin Cannulated Headless Screws | KLS Martin L.P. | 2016-12-19 | Traditional | PDF ↗ |
| K160946 | 4.0 and 6.5 Cancellous Bone Screw and Washer | Smv Scientific | 2016-12-05 | Traditional | PDF ↗ |
| K161778 | ToeTac 10° Hammertoe Fixation System | Restore Surgical, LLC Dba Instratek | 2016-11-22 | Traditional | PDF ↗ |
| K161597 | Tyber Medical BioTy® Nanotopography Trauma Screw | Tyber Medical, LLC | 2016-11-16 | Traditional | PDF ↗ |
| K160791 | AmorChem Titanium Porous Fixation Device | Amorchem Holdings, Inc. | 2016-11-15 | Traditional | PDF ↗ |
| K161449 | HammerTech Fixation System | Fusion Orthopedics, LLC | 2016-10-11 | Traditional | PDF ↗ |
| K160174 | I.B.S. 2.0 Osteosynthesis screw | In2bones Sas | 2016-10-06 | Traditional | PDF ↗ |
| K153065 | The Hammertoe Correction System | Life Spine, Inc. | 2016-08-01 | Traditional | PDF ↗ |
| K161058 | Cannulated Screw | Miami Device Solutions, LLC | 2016-07-29 | Traditional | PDF ↗ |
| K161539 | Arthrosurface Bone Screws | Arthrosurface, Inc. | 2016-06-30 | Special | PDF ↗ |
| K160169 | The Life Spine Subtalar Implant System | Life Spine | 2016-06-23 | Traditional | PDF ↗ |
| K160617 | Large Screws Range | Newclip Technics | 2016-06-03 | Traditional | PDF ↗ |
| K160427 | dynaMX(TM) Nitinol Compression Screw | Mx Orthopedics, Corp. | 2016-06-03 | Traditional | PDF ↗ |
| K160304 | OsteoBullet Compression Screw | Phalanx Innovations | 2016-04-29 | Traditional | PDF ↗ |
| K160548 | MC-Subtalar(TM) II | Merete Medical GmbH | 2016-04-29 | Traditional | PDF ↗ |
| K153638 | Bicortical Fixation Screw & Washer Nut System | First Ray, LLC | 2016-04-19 | Traditional | PDF ↗ |
| K160603 | SMV Scientific Schanz Screws | Smv Scientific | 2016-03-28 | Traditional | PDF ↗ |
| K160058 | Biomet Variable Pitch Compression Screw System | Biomet, Inc. | 2016-03-09 | Traditional | PDF ↗ |
| K151708 | RECON system - Compression Screws | Normed Medizin-Technik GmbH | 2016-03-02 | Traditional | PDF ↗ |
| K153575 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2016-02-26 | Traditional | PDF ↗ |
| K153759 | SIGN Compression Screw System | Sign Fracture Care International | 2016-02-25 | Traditional | PDF ↗ |
| K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws | Merete Medical GmbH | 2016-02-12 | Traditional | PDF ↗ |
| K143596 | MINIARS SCREWS | Overmed Srl. | 2016-02-05 | Traditional | PDF ↗ |
| K151701 | Tenodesis screw system | Normed Medizin-Technik GmbH | 2016-01-26 | Traditional | PDF ↗ |
| K153333 | Epic Extremity Cannulated Screw System | Epic Extremity, LLC | 2016-01-19 | Traditional | PDF ↗ |
| K153338 | Tiger Cannulated Screw System | Trilliant Surgical, Ltd. | 2016-01-14 | Traditional | PDF ↗ |
| K153154 | Asnis JFX System | Stryker Trauma AG | 2015-12-28 | Traditional | PDF ↗ |
| K153378 | Monster BITE Screw System | Paragon 28 | 2015-12-21 | Special | PDF ↗ |
| K153180 | Tyber Medical MST Trauma Screw | Tyber Medical, LLC | 2015-11-25 | Special | PDF ↗ |
| K153182 | SELF- COMPRESSIVE SCREW | Neosteo | 2015-11-25 | Traditional | PDF ↗ |
| K152841 | Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws | Zimmer, Inc. | 2015-11-24 | Traditional | PDF ↗ |
| K150211 | EzFuze Implant System | Vilex IN Tennessee, Inc. | 2015-11-10 | Traditional | PDF ↗ |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion System | Ascension Orthopedics | 2015-10-29 | Traditional | PDF ↗ |
| K152710 | HammerFiX Device | Extremity Medical, LLC | 2015-10-15 | Special | PDF ↗ |
| K150693 | PHIN-FX Cannulated Lag Screw System | Ascent Medical, LLC | 2015-10-13 | Traditional | PDF ↗ |
| K152072 | CrossRoads Screw System | Crossroads Extremity Systems, LLC | 2015-09-23 | Special | PDF ↗ |
| K151270 | CrossTIE Intraosseous Fixation System | Crossroads Extremity Systems, LLC | 2015-09-04 | Traditional | PDF ↗ |
| K151838 | PRO-TOE Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2015-09-04 | Traditional | PDF ↗ |
| K151241 | Synchro-Medical TIGER TRACK Screw System | Synchro Medical | 2015-08-07 | Traditional | PDF ↗ |
| K150871 | ForeFoot STP System | Tornier, Inc. | 2015-08-04 | Traditional | PDF ↗ |
| K151146 | N-Force Fixation System | Innovision, Inc. | 2015-07-24 | Traditional | PDF ↗ |
| K151418 | Monster Screw System | Paragon 28 | 2015-07-15 | Special | PDF ↗ |
| K151021 | OsteoMed Cannulated Screw System | Osteomed Corp. | 2015-07-15 | Special | PDF ↗ |
| K150981 | SMV Scientific Bone Screws | Smv Scientific | 2015-06-23 | Traditional | PDF ↗ |
| K150376 | Sonoma Cancellous Bone Screw and Washer | Sonoma Orthopedics Products, Inc. | 2015-06-12 | Traditional | PDF ↗ |
| K150443 | ToeTac Hammertoe Fixation System | Restore Surgical, LLC Dba Instratek | 2015-06-04 | Traditional | PDF ↗ |
| K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2015-05-26 | Special | PDF ↗ |
| K151078 | Arthrex RetroFusion Screw | Arthrex, Inc. | 2015-05-15 | Special | PDF ↗ |
| K150126 | Life Spine Cannulated Screws | Life Spine, Inc. | 2015-05-11 | Traditional | PDF ↗ |
| K150213 | Subtalar Spacer System (STS) | Wrightmedicaltechnologyinc | 2015-05-08 | Traditional | PDF ↗ |
| K150772 | Snap-Off Self-Compressive Screw | Neosteo | 2015-05-08 | Traditional | PDF ↗ |
| K150974 | aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium | Aap Implantate AG | 2015-04-29 | Special | PDF ↗ |
| K150252 | PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2015-04-29 | Traditional | PDF ↗ |
| K150188 | SMV Scientific 4.5 mm Bone Screws | Summit Medventures | 2015-04-29 | Traditional | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.