ClearanceBrief
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)
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Top companies in HWC

Company510(k)sRecalls
Zimmer, Inc.1250
Biomet, Inc.2427
Arthrex, Inc.471
Acumed, LLC535
Depuy Mitek, A Johnson & Johnson Co.1321
Synthes (Usa)313
Smith & Nephew, Inc.276
Smith & Nephew Inc., Endoscopy Division130
Wrightmedicaltechnologyinc310
Stryker Howmedica Osteonics Corp.030
Decided510(k)Device and applicantCode
Nov 25, 2013K132217ARTHREX COMPRESSION FT SCREWS
Arthrex, Inc.
HWC
Nov 20, 2013K132893EDGE ORTHOPAEDICS BITE COMPRESSION SCREW
Icon Orthopaedic Concepts Dba Edge Orthopaedics
HWC
Oct 30, 2013K132248FLOWER BONE SCREW SET
Flower Orthopedics Corporation
HWC
Sep 19, 2013K130810ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
Zimmer, Inc.
HWC
Aug 28, 2013K131471SELF-COMPRESSIVE SCREW
Neosteo
HWC
Aug 21, 2013K130627SWING-OFF SCREW
Advanced Interventional Technology, LLC
HWC
Jul 26, 2013K131264KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
Gebr. Brasseler GmbH & Co. KG
HWC
Jul 25, 2013K131620JONES-FX FRACTURE SYSTEM
Instratek, Inc.
HWC
Jul 25, 2013K130859HAMMERTOE CORRECTION SYSTEM
Arthrosurface, Inc.
HWC
May 31, 2013K131324MAXTORQUE SCREW SYSTEM
Orthohelix Surgical Designs, Inc.
HWC
May 31, 2013K130954ARS SCREW; SLANT SCREW
Advanced Interventional Technology, LLC
HWC
May 31, 2013K130412OSTEOMED EXTREMIFUSE SYSTEM
Osteomed
HWC
May 31, 2013K130319MEDLINE CANNULATED SCREW
Medline Industries, Inc.
HWC
Apr 22, 2013K130590AAP CANNULATED SCREW 2.0
Aap Implantate AG, DE
HWC
Apr 11, 2013K130120EXTREMITY MEDICAL IP FUSION SYSTEM
Extremity Medical, LLC
HWC
Apr 5, 2013K130400MERETEC CS, CORTICAL SCREWS
Merete Medical GmbH, DE
HWC
Apr 5, 2013K124027MONSTER SCREW SYSTEM
Apogee Orthosolutions
HWC
Mar 18, 2013K123890ACUMED CANNULATED SCREW SYSTEM
Acumed, LLC
HWC
Feb 27, 2013K123672INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
Inion OY, FI
HWC
Feb 1, 2013K123362MILAGRO ADVANCE INTERFERENCE SCREW
Depuy Mitek, A Johnson & Johnson Company
HWC
Dec 10, 2012K122489EMERGE MEDICAL SOLID BONE SCREWS
Emerge Medical
HWC
Nov 20, 2012K122596ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
Smith & Nephew, Inc.
HWC
Nov 7, 2012K122959HAMMER TOE IMPLANT
Trilliant Surgical, Ltd.
HWC
Nov 7, 2012K122738GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
Solana Surgical, LLC
HWC
Nov 7, 2012K121277Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
Z-Medical GmbH & Co. KG, DE
HWC
Oct 9, 2012K122031NEXTRA TI HAMMERTOE CORRECTION SYSTEM
Nextremity Solutions, LLC
HWC
Oct 4, 2012K121682ACTIVE SCREW BONE SCREW
Intelligent Implant Systems, LLC
HWC
Sep 27, 2012K121713PMT BONE SCREWS
Providence Medical Technology, Inc.
HWC
Aug 20, 2012K121148SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D
Medical Design, LLC
HWC
Jul 18, 2012K121417XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
Extremity Medical, LLC
HWC
Jul 18, 2012K121349IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
Extremity Medical, LLC
HWC
Jun 5, 2012K113388CITIEFFE-TITANIUM CANNULATED SCREW
Citieffe
HWC
May 25, 2012K113006I-FUSE HAMMER TOE SYSTEMS
Orthopro, LLC
HWC
May 17, 2012K120493MINI CANNULATED HEADED AND HEADLESS SCREW SET
Instratek, Inc.
HWC
May 11, 2012K120449HEALIX ADVANCE PEEK ANCHOR
Depuy Mitek
HWC
Apr 24, 2012K120645PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
Wrightmedicaltechnologyinc
HWC
Apr 10, 2012K120390SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
Solana Surgical, LLC
HWC
Jan 23, 2012K111971SYNDE-LOCK SYNDESMOSIS REPAIR KIT
Tarsus Medical, Inc.
HWC
Jan 13, 2012K112727MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL
Medical Facets
HWC
Jan 4, 2012K112240DYNA LOCKING CANNULATED SCREW
U&I Corp., KR
HWC
Dec 22, 2011K113591COLS PEEK
Fournitures Hospitalieres Industrie, FR
HWC
Dec 20, 2011K113399IFS SUBTALAR IMPLANT
Internal Fixation Systems, Inc.
HWC
Dec 19, 2011K112885ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
Zimmer, Inc.
HWC
Dec 19, 2011K110895ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
Ortho Solutions Limited
HWC
Dec 13, 2011K112672HEADLESS COMPRESSION SCREW
Skeletal Dynamics, LLC
HWC
Dec 12, 2011K112658OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM
Osteospring Medical, Inc.
HWC
Dec 9, 2011K113084RENOVIS CANNULATED SCREW SYSTEM
Renovis Surgical Technologies, LLC
HWC
Dec 9, 2011K112028SI-LOK SACROILIAC JOINT FIXATION SYSTEM
Globus Medical, Inc.
HWC
Dec 6, 2011K111834DISCO SUBTALAR IMPLANT
Trilliant Surgical, Ltd.
HWC
Dec 5, 2011K112583SYNTHES CORTICAL SCREWS
Synthes (USA) Products, LLC
HWC

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