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 4 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw | Zimmer, Inc. | 2015-03-31 | Traditional | PDF ↗ |
| K142776 | Flow-Screw | Flow-Fx, LLC | 2015-03-23 | Traditional | PDF ↗ |
| K150309 | Extremity Medical Calcaneal Osteotomy Device | Extremity Medical, LLC | 2015-03-04 | Special | PDF ↗ |
| K141401 | EASY OUT | Feet For Life Podiatry Center | 2015-02-20 | Traditional | PDF ↗ |
| K143229 | Nexis osteosynthesis compressive screws | Novastep | 2015-02-06 | Traditional | PDF ↗ |
| K143146 | Nexis osteosynthesis snap-off screws | Novastep | 2015-02-06 | Traditional | PDF ↗ |
| K143402 | Extremity Medical Calcaneal Osteotomy Device | Extremity Medical, LLC | 2015-02-04 | Traditional | PDF ↗ |
| K143460 | Cannulated Screw System | Wrightmedicaltechnologyinc | 2015-01-23 | Traditional | PDF ↗ |
| K143614 | Arthrex Low Profile Screws | Arthrex, Inc. | 2015-01-16 | Special | PDF ↗ |
| K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015-01-16 | Traditional | PDF ↗ |
| K143624 | Headless Compression Screw System | Skeletal Dynamics, LLC | 2015-01-13 | Special | PDF ↗ |
| K142057 | INFIX CANNULATED SCREW SYSTEM | Infix Medical, LLC | 2015-01-13 | Traditional | PDF ↗ |
| K141857 | CrossTie Intraosseous Fixation System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015-01-08 | Traditional | PDF ↗ |
| K143188 | 3.Omm Biomet Cannulated Screw System | Biomet Manufacturing Corp | 2014-12-30 | Traditional | PDF ↗ |
| K142528 | AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm | Agent Medical, LLC | 2014-12-22 | Traditional | PDF ↗ |
| K142707 | AIS Odontoid Fracture Fixation System | Aesculap Implant System, Inc. | 2014-12-19 | Traditional | PDF ↗ |
| K142490 | ProxiFuse Hammer Toe Device | Cartiva, Inc. | 2014-12-15 | Traditional | PDF ↗ |
| K142585 | PhaLinx Hammertoe System | Wrightmedicaltechnologyinc | 2014-11-20 | Traditional | PDF ↗ |
| K130019 | J-SCREW COMPRESSION SCREW | Competitive Engineering, Inc. | 2014-11-18 | Traditional | PDF ↗ |
| K142658 | Biomet Headless Compression and Twist-off Screws | Biomet Manufacturing Corp | 2014-11-13 | Traditional | PDF ↗ |
| K142534 | HyProCure II | Graham Medical Technologies, LLC Dba Gramedica | 2014-10-03 | Traditional | PDF ↗ |
| K142442 | MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM | Zimmer, Inc. | 2014-10-03 | Traditional | PDF ↗ |
| K141290 | HELICAL RIDGE PEEK INTERFERENCE SCREW | MedShape, Inc. | 2014-09-29 | Traditional | PDF ↗ |
| K141949 | CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM | Aap Implantate AG | 2014-09-12 | Traditional | PDF ↗ |
| K141937 | TRIDENT FUSION IMPLANT | Vilex IN Tennessee, Inc. | 2014-09-10 | Traditional | PDF ↗ |
| K132912 | DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT | In2bones Sas | 2014-07-30 | Traditional | PDF ↗ |
| K140962 | NORMED VARIO SUBTALAR SCREW | Normed Nedizin Technik GmbH | 2014-07-03 | Traditional | PDF ↗ |
| K140891 | BIOMET CANNULATED SCREW SYSTEM | Biomet, Inc. | 2014-06-03 | Traditional | PDF ↗ |
| K133662 | SMITH & NEPHEW CANNULATED CAPTURED SCREW | Smith & Nephew, Inc. | 2014-05-15 | Traditional | PDF ↗ |
| K140741 | SALVATION BEAMS AND BOLTS SYSTEM | Wrightmedicaltechnologyinc | 2014-05-15 | Traditional | PDF ↗ |
| K140952 | CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW | Wrightmedicaltechnologyinc | 2014-05-15 | Special | PDF ↗ |
| K140408 | SALVATION OSTEOPENIC SCREW | Wrightmedicaltechnologyinc | 2014-05-14 | Traditional | PDF ↗ |
| K140970 | ONE-PIECE PEEK FUSION IMPLANT | Mtp Solutions, LLC | 2014-05-13 | Special | PDF ↗ |
| K131920 | STABILIZATION SCREW | In2bones Sas | 2014-05-01 | Traditional | PDF ↗ |
| K132911 | I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW | In2bones Sas | 2014-04-04 | Traditional | PDF ↗ |
| K133636 | EXTREMITY MEDICAL HAMMERTOE DEVICE | Extremity Medical, LLC | 2014-03-28 | Traditional | PDF ↗ |
| K133515 | PEEK FUSION IMPLANT | Mtp Solutions, LLC | 2014-03-28 | Traditional | PDF ↗ |
| K133842 | TYBER MEDICAL TRAUMA SCREW | Tyber Medical, LLC | 2014-03-20 | Traditional | PDF ↗ |
| K133713 | CHARLOTTE (TM) SNAP-OFF SCREW | Wrightmedicaltechnologyinc | 2014-03-07 | Special | PDF ↗ |
| K140148 | PRO-TOE HAMMERTOE FIXATION SYSTEM | Wrightmedicaltechnologyinc | 2014-03-07 | Traditional | PDF ↗ |
| K132244 | N-FORCE FIXATION SYSTEM | Innovision, Inc. | 2014-03-06 | Traditional | PDF ↗ |
| K133451 | FIXOS SCREW SYSTEM | Stryker Trauma AG | 2014-02-28 | Traditional | PDF ↗ |
| K140283 | OSTEOMED EXTREMIFUSE SYSTEM | Osteomed | 2014-02-28 | Special | PDF ↗ |
| K130613 | CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM | Laura Cattabriga | 2014-01-22 | Traditional | PDF ↗ |
| K133440 | AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION | Stryker Trauma AG | 2013-12-18 | Special | PDF ↗ |
| K133460 | APTUS CANNULATED COMPRESSION SCREWS | Medartis AG | 2013-12-18 | Traditional | PDF ↗ |
| K132910 | DEPUY SYNTHES SPINE DENS ACCESS SYSTEM | Synthes USA Products, LLC | 2013-12-16 | Traditional | PDF ↗ |
| K133035 | NORMED PELLEGRIN CALCANEUS STOP SCREW | Normed Medizin-Technik GmbH | 2013-12-13 | Traditional | PDF ↗ |
| K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) | Pega Medical, Inc. | 2013-11-27 | Traditional | PDF ↗ |
| K132217 | ARTHREX COMPRESSION FT SCREWS | Arthrex, Inc. | 2013-11-25 | Traditional | PDF ↗ |
| K132893 | EDGE ORTHOPAEDICS BITE COMPRESSION SCREW | Icon Orthopaedic Concepts Dba Edge Orthopaedics | 2013-11-20 | Traditional | PDF ↗ |
| K132248 | FLOWER BONE SCREW SET | Flower Orthopedics Corporation | 2013-10-30 | Traditional | PDF ↗ |
| K130810 | ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM | Zimmer, Inc. | 2013-09-19 | Traditional | PDF ↗ |
| K131471 | SELF-COMPRESSIVE SCREW | Neosteo | 2013-08-28 | Traditional | PDF ↗ |
| K130627 | SWING-OFF SCREW | Advanced Interventional Technology, LLC | 2013-08-21 | Traditional | PDF ↗ |
| K131264 | KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS | Gebr. Brasseler GmbH & Co. KG | 2013-07-26 | Traditional | PDF ↗ |
| K130859 | HAMMERTOE CORRECTION SYSTEM | Arthrosurface, Inc. | 2013-07-25 | Traditional | PDF ↗ |
| K131620 | JONES-FX FRACTURE SYSTEM | Instratek, Inc. | 2013-07-25 | Traditional | PDF ↗ |
| K131324 | MAXTORQUE SCREW SYSTEM | Orthohelix Surgical Designs, Inc. | 2013-05-31 | Traditional | PDF ↗ |
| K130319 | MEDLINE CANNULATED SCREW | Medline Industries, Inc. | 2013-05-31 | Traditional | PDF ↗ |
| K130412 | OSTEOMED EXTREMIFUSE SYSTEM | Osteomed | 2013-05-31 | Traditional | PDF ↗ |
| K130954 | ARS SCREW; SLANT SCREW | Advanced Interventional Technology, LLC | 2013-05-31 | Traditional | PDF ↗ |
| K130590 | AAP CANNULATED SCREW 2.0 | Aap Implantate AG | 2013-04-22 | Traditional | PDF ↗ |
| K130120 | EXTREMITY MEDICAL IP FUSION SYSTEM | Extremity Medical, LLC | 2013-04-11 | Traditional | PDF ↗ |
| K124027 | MONSTER SCREW SYSTEM | Apogee Orthosolutions | 2013-04-05 | Traditional | PDF ↗ |
| K130400 | MERETEC CS, CORTICAL SCREWS | Merete Medical GmbH | 2013-04-05 | Special | PDF ↗ |
| K123890 | ACUMED CANNULATED SCREW SYSTEM | Acumed, LLC | 2013-03-18 | Traditional | PDF ↗ |
| K123672 | INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) | Inion OY | 2013-02-27 | Traditional | PDF ↗ |
| K123362 | MILAGRO ADVANCE INTERFERENCE SCREW | Depuy Mitek, A Johnson & Johnson Company | 2013-02-01 | Traditional | PDF ↗ |
| K122489 | EMERGE MEDICAL SOLID BONE SCREWS | Emerge Medical | 2012-12-10 | Traditional | PDF ↗ |
| K122596 | ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS | Smith & Nephew, Inc. | 2012-11-20 | Traditional | PDF ↗ |
| K122738 | GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-11-07 | Traditional | PDF ↗ |
| K122959 | HAMMER TOE IMPLANT | Trilliant Surgical, Ltd. | 2012-11-07 | Traditional | PDF ↗ |
| K121277 | Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE | Z-Medical GmbH & Co. KG | 2012-11-07 | Traditional | PDF ↗ |
| K122031 | NEXTRA TI HAMMERTOE CORRECTION SYSTEM | Nextremity Solutions, LLC | 2012-10-09 | Traditional | PDF ↗ |
| K121682 | ACTIVE SCREW BONE SCREW | Intelligent Implant Systems, LLC | 2012-10-04 | Traditional | PDF ↗ |
| K121713 | PMT BONE SCREWS | Providence Medical Technology, Inc. | 2012-09-27 | Traditional | PDF ↗ |
| K121148 | SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D | Medical Design, LLC | 2012-08-20 | Traditional | PDF ↗ |
| K121349 | IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER | Extremity Medical, LLC | 2012-07-18 | Special | PDF ↗ |
| K121417 | XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM | Extremity Medical, LLC | 2012-07-18 | Special | PDF ↗ |
| K113388 | CITIEFFE-TITANIUM CANNULATED SCREW | Citieffe | 2012-06-05 | Traditional | PDF ↗ |
| K113006 | I-FUSE HAMMER TOE SYSTEMS | Orthopro, LLC | 2012-05-25 | Traditional | PDF ↗ |
| K120493 | MINI CANNULATED HEADED AND HEADLESS SCREW SET | Instratek, Inc. | 2012-05-17 | Traditional | PDF ↗ |
| K120449 | HEALIX ADVANCE PEEK ANCHOR | Depuy Mitek | 2012-05-11 | Traditional | PDF ↗ |
| K120645 | PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION | Wrightmedicaltechnologyinc | 2012-04-24 | Traditional | PDF ↗ |
| K120390 | SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET | Solana Surgical, LLC | 2012-04-10 | Traditional | PDF ↗ |
| K111971 | SYNDE-LOCK SYNDESMOSIS REPAIR KIT | Tarsus Medical, Inc. | 2012-01-23 | Traditional | PDF ↗ |
| K112727 | MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL | Medical Facets | 2012-01-13 | Traditional | PDF ↗ |
| K112240 | DYNA LOCKING CANNULATED SCREW | U&I Corp. | 2012-01-04 | Traditional | PDF ↗ |
| K113591 | COLS PEEK | Fournitures Hospitalieres Industrie | 2011-12-22 | Traditional | PDF ↗ |
| K113399 | IFS SUBTALAR IMPLANT | Internal Fixation Systems, Inc. | 2011-12-20 | Traditional | PDF ↗ |
| K112885 | ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY | Zimmer, Inc. | 2011-12-19 | Traditional | PDF ↗ |
| K110895 | ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS | Ortho Solutions Limited | 2011-12-19 | Traditional | PDF ↗ |
| K112672 | HEADLESS COMPRESSION SCREW | Skeletal Dynamics, LLC | 2011-12-13 | Traditional | PDF ↗ |
| K112658 | OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM | Osteospring Medical, Inc. | 2011-12-12 | Traditional | PDF ↗ |
| K113084 | RENOVIS CANNULATED SCREW SYSTEM | Renovis Surgical Technologies, LLC | 2011-12-09 | Special | PDF ↗ |
| K112028 | SI-LOK SACROILIAC JOINT FIXATION SYSTEM | Globus Medical, Inc. | 2011-12-09 | Traditional | PDF ↗ |
| K111834 | DISCO SUBTALAR IMPLANT | Trilliant Surgical, Ltd. | 2011-12-06 | Traditional | PDF ↗ |
| K112583 | SYNTHES CORTICAL SCREWS | Synthes (USA) Products, LLC | 2011-12-05 | Traditional | PDF ↗ |
| K111908 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | Biomet Microfixation, Inc. | 2011-11-29 | Traditional | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.