FDA 510(k) Applications for Medical Device Product Code "JEC"
(Component, Traction, Invasive)

FDA 510(k) Number Applicant Device Name Decision Date
K914858 ACE MEDICAL CO. ACE OPEN-BACK HALO RING 11/21/1991
K933968 ACE MEDICAL CO. ACE PELVIC STABILIZER 06/16/1994
K791466 ACE ORTHOPEDIC MANUFACTURING CO. ACE EXTERNAL BONE CLAMP PART #S11 08/16/1979
K936045 ACE ORTHOPEDIC MANUFACTURING CO. ACE UNILATERAL FIXATOR II 02/22/1994
K781841 ACE ORTHOPEDIC MANUFACTURING CO. BAR, DISTRACTION 11/08/1978
K781839 ACE ORTHOPEDIC MANUFACTURING CO. BONE CLAMP, ACE EXTERNAL 11/08/1978
K781840 ACE ORTHOPEDIC MANUFACTURING CO. EXTERNAL ARTICULATION 11/08/1978
K943857 ACUMED, INC. EXTERNAL FIXATOR 01/27/1995
K952330 ACUMED, INC. EXTERNAL FIXATOR 10/05/1995
K965029 ACUMED, INC. STABLELOC II EXTERNAL FIXATOR 02/19/1997
K894959 ALPHATEC MFG., INC. CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO 09/14/1990
K884798 AMERICAN MEDICAL ELECTRONICS, INC. AME PINSITE SHIELD(TM) 02/10/1989
K171863 Anjon Holdings, LLC Anjon Bremer Halo System 03/19/2018
K931578 APPLIED OSTEO SYSTEMS, INC. TEXAS SCOTTISH RITE EASY/LOCK FIXATOR 02/22/1994
K981423 AUTOGENESIS, INC. AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 05/20/1998
K013818 AUTOGENESIS, INC. AUTOGENESIS AUTOMATOR, MODEL M1000 12/05/2001
K781793 B.G. ORTHOPEDIC CORP. FRAME, UNIVERSAL DAY 11/03/1978
K954838 BIODYNAMIC TECHNOLOGIES, INC. EZ FIX 01/24/1996
K915800 BREMER MEDICAL, INC. BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN 03/16/1992
K901984 BUCKMAN CO., INC. ACE WIRE TENSION CLAMP 06/21/1990
K894982 BUCKMAN CO., INC. ACE WIRE TENSION CLAMP 01/11/1990
K884242 CHICK MEDICAL PRODUCTS MODIFIED CHICK AMBULATORY HALO 12/29/1988
K802814 CINTOR ORTHOPAEDIC DIV. ORTHOFIX AXIALEXTERNAL FIXATION SYS. 12/10/1980
K903105 DANEK MEDICAL, INC. OLIVE K-WIRES 09/06/1990
K993099 DEPUY ACROMED BREMER HALO SYSTEM TITANIUM SKULL PIN 12/15/1999
K761088 DEPUY, INC. DEPUY MODIFIED SKELETAL TRACTION PIN 12/17/1976
K800184 DOWNS SURGICAL LTD. OXFORD EXTERNAL FIXATION SYSTEM 02/11/1980
K831576 ELECTRO-BIOLOGY, INC. ORTHOFIX 06/08/1983
K792561 GENY MEDICAL, INC. "MINI-H-FIXATION 12/19/1979
K984442 HAND BIOMECHANICS LAB, INC. AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 02/12/1999
K072432 HAND BIOMECHANICS LAB, INC. F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE 01/09/2008
K030519 HAND BIOMECHANICS LAB, INC. WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS 06/10/2003
K803166 HOWMEDICA CORP. DOUBLE BALL JOINT 01/09/1981
K802723 HOWMEDICA CORP. EXTENDED BALLJOINT GRIP 11/19/1980
K802722 HOWMEDICA CORP. EXTERNAL FIXATION SYSTEM 11/19/1980
K852397 HOWMEDICA CORP. EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129) 08/09/1985
K802776 HOWMEDICA CORP. HOFFMAN LEG LENGTHENING DEVICE 11/19/1980
K971755 HOWMEDICA CORP. HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM 07/17/1997
K952730 HOWMEDICA CORP. HOFFMANN II EXTERNAL FIXATION SYSTEM 09/08/1995
K934698 HOWMEDICA CORP. HOWMEDICA MONO-TUBE SINGLE PIN CLAMP 02/22/1994
K963614 HOWMEDICA CORP. MONOTUBE CARBON TUBE 11/06/1996
K961618 HOWMEDICA CORP. MONOTUBE TUBE TO RING CLAMP 05/28/1996
K954667 HOWMEDICA CORP. MONOTUBE TUBE-TO-TUBE CLAMP 01/11/1996
K031941 HOWMEDICA OSTEONICS CORP. HOFFMANN II COMPACT BALTIMORE COUPLING 07/24/2003
K003848 HOWMEDICA OSTEONICS CORP. HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST 01/11/2001
K961916 HOWMEDICA, INC. HOFFMANN II CARBON CONNECTING ROD 08/01/1996
K936124 HOWMEDICA, INC. HOWMEDICA MONOTUBE T-CONNECTOR 02/22/1994
K920117 ITM CORP. HALO ESPRIT 10/06/1992
K822780 JEROME MEDICAL CERVICAL BRACE 10/06/1982
K882877 JEROME MEDICAL JMS CERVICAL TRACTION DEVICE/HALO DEVICE 09/30/1988
K930153 JEROME MEDICAL SYSTEM III HALO RING 08/06/1993
K833114 JOHNSON & JOHNSON PROFESSIONALS, INC. OXFORD MARK 2 EXTERNAL FIXATOR 10/20/1983
K881896 KIRSCHNER MEDICAL CORP. KIRSCHNER SUPER-FIXATION SYSTEM 07/28/1988
K042066 KLS-MARTIN L.P. KLSA MARTIN HAND DISTRACTOR 08/25/2004
K881673 LIMA-LTO, INC. LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER 06/03/1988
K880282 LIMA-LTO, INC. LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER 02/18/1988
K032427 MERIDAN MEDICAL FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM 10/09/2003
K944092 ORTHOFIX SRL ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM 04/04/1995
K920149 OSTEO AG OSTEO EX-FI-RE 04/09/1992
K991732 OWANDAR MEDICAL LTD CENTRAFIX EXTERNAL FIXATOR 05/21/1999
K840856 PRECISION MEDICAL DEVICES, INC. MODULAR CONSTRUCT FRAME EXTERNAL FIXA 04/25/1984
K770066 RICHARD F. KRONNER, M.D. TIBIAL COMPRESSION FRAM FOR FRACTURES 03/30/1977
K830154 RICHARD'S MEDICAL EQUIP., INC. COLLES FRACTURE FRAME 02/02/1983
K841334 RICHARDS MEDICAL CO., INC. RICHARDS FIXATOR SYSTEM 05/16/1984
K082679 SINTEA BIOTECH, INC. LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X 04/07/2009
K022065 SINTEA BIOTECH, INC. SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X 08/06/2002
K770388 SISAN ASSOC. FRACTURE REDUCTION SYS., MODEL OR 1001 03/14/1977
K012193 SMITH & NEPHEW, INC. AMC ANTIMICROBIAL PIN/WIRE SLEEVE 07/11/2002
K022676 SMITH & NEPHEW, INC. ORTHOGUARD AB ANTIMICROBIAL SLEEVE 09/23/2002
K102885 STRYKER CORP. HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX 01/14/2011
K163028 SURGICAL INSTRUMENT SERVICE AND SAVINGS INC Medline ReNewal Reprocessed Stryker External Fixation Devices 12/28/2016
K922796 SYNTHES (USA) PELVIC C-CLAMP 03/10/1994
K071476 SYNTHES (USA) SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP 08/24/2007
K894098 SYNTHES (USA) SYNTHES EXTERNAL FIXATION BONE CLIP 04/30/1990
K960782 SYNTHES (USA) TITANIUM TUBE TO TUBE CLAMP 05/08/1996
K842493 THE HAND BIOMECHANICS RESEARCH LABORATORY AGEE EXTERNAL FIXATOR 02/13/1985
K892638 TRACER MEDICAL TRACER DYNAMIC AXIAL FIXATION 08/11/1989
K132731 VIRAK ORTHOPEDIC RESEARCH, LLC DIGIFIX EXTERNAL FIXATION SYSTEM 01/10/2014
K872538 VITAPHORE CORP. VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS 07/10/1987
K842343 ZIMMER, INC. SABA-COOMBS MINI EXTERNAL FIXATOR 09/11/1984
K790262 ZIMMER, INC. UNIVERSAL EXTERNAL FIXATION ASSEMBLY 02/13/1979


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact