Panels › Orthopedic › Product code JEC · Class 2
Component, Traction, Invasive
Regulation 888.3040
0510(k)s in 12 months (85 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in JEC
| Company | 510(k)s | Recalls |
|---|---|---|
| Howmedica Corp. | 13 | 0 |
| Ace Orthopedic Manufacturing Co. | 5 | 0 |
| Hand Biomechanics Lab, Inc. | 4 | 1 |
| Synthes (Usa) | 4 | 0 |
| Acu Med, Inc. | 3 | 0 |
| Anjon Holdings, LLC | 2 | 1 |
| Jerome Medical | 3 | 0 |
| Ace Medical Co. | 2 | 0 |
| Autogenesis, Inc. | 2 | 0 |
| Buckman Co., Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 23, 2021 | K203605 | SteriTrak Arbutus Medical, Inc., CA | JEC |
| Mar 2, 2020 | K193256 | Anjon Bremer Halo System Anjon Holdings, LLC | JEC |
| Oct 10, 2019 | K192465 | DigiFix Sterile Kit Virak Orthopedics, LLC | JEC |
| Oct 22, 2018 | K181192 | PIP Fix Hand Biomechanics Lab, Inc. | JEC |
| Mar 19, 2018 | K171863 | Anjon Bremer Halo System Anjon Holdings, LLC | JEC |
| Dec 28, 2016 | K163028 | Medline ReNewal Reprocessed Stryker External Fixation Devices Surgical Instrument Service and Savings, Inc. | JEC |
| Jan 10, 2014 | K132731 | DIGIFIX EXTERNAL FIXATION SYSTEM Virak Orthopedic Research, LLC | JEC |
| Jan 14, 2011 | K102885 | HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX Stryker Corp. | JEC |
| Apr 7, 2009 | K082679 | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X Sintea Biotech, Inc. | JEC |
| Jan 9, 2008 | K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE Hand Biomechanics Lab, Inc. | JEC |
| Aug 24, 2007 | K071476 | SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP Synthes (Usa) | JEC |
| Aug 25, 2004 | K042066 | KLSA MARTIN HAND DISTRACTOR KLS-Martin L.P. | JEC |
| Oct 9, 2003 | K032427 | FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM Meridan Medical | JEC |
| Jul 24, 2003 | K031941 | HOFFMANN II COMPACT BALTIMORE COUPLING Howmedica Osteonics Corp. | JEC |
| Jun 10, 2003 | K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS Hand Biomechanics Lab, Inc. | JEC |
| Sep 23, 2002 | K022676 | ORTHOGUARD AB ANTIMICROBIAL SLEEVE Smith & Nephew, Inc. | JEC |
| Aug 6, 2002 | K022065 | SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X Sintea Biotech, Inc. | JEC |
| Jul 11, 2002 | K012193 | AMC ANTIMICROBIAL PIN/WIRE SLEEVE Smith & Nephew, Inc. | JEC |
| Dec 5, 2001 | K013818 | AUTOGENESIS AUTOMATOR, MODEL M1000 Autogenesis, Inc. | JEC |
| Jan 11, 2001 | K003848 | HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST Howmedica Osteonics Corp. | JEC |
| Dec 15, 1999 | K993099 | BREMER HALO SYSTEM TITANIUM SKULL PIN Depuyacromed | JEC |
| May 21, 1999 | K991732 | CENTRAFIX EXTERNAL FIXATOR Owandar Medical, Ltd., GB | JEC |
| Feb 12, 1999 | K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 Hand Biomechanics Lab, Inc. | JEC |
| May 20, 1998 | K981423 | AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 Autogenesis, Inc. | JEC |
| Jul 17, 1997 | K971755 | HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM Howmedica Corp. | JEC |
| Feb 19, 1997 | K965029 | STABLELOC II EXTERNAL FIXATOR Acu Med, Inc. | JEC |
| Nov 6, 1996 | K963614 | MONOTUBE CARBON TUBE Howmedica Corp. | JEC |
| Aug 1, 1996 | K961916 | HOFFMANN II CARBON CONNECTING ROD Howmedica, Inc. | JEC |
| May 28, 1996 | K961618 | MONOTUBE TUBE TO RING CLAMP Howmedica Corp. | JEC |
| May 8, 1996 | K960782 | TITANIUM TUBE TO TUBE CLAMP Synthes (Usa) | JEC |
| Jan 24, 1996 | K954838 | EZ FIX Biodynamic Technologies, Inc. | JEC |
| Jan 11, 1996 | K954667 | MONOTUBE TUBE-TO-TUBE CLAMP Howmedica Corp. | JEC |
| Oct 5, 1995 | K952330 | EXTERNAL FIXATOR Acu Med, Inc. | JEC |
| Sep 8, 1995 | K952730 | HOFFMANN II EXTERNAL FIXATION SYSTEM Howmedica Corp. | JEC |
| Apr 4, 1995 | K944092 | ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM Orthofix Srl | JEC |
| Jan 27, 1995 | K943857 | EXTERNAL FIXATOR Acu Med, Inc. | JEC |
| Jun 16, 1994 | K933968 | ACE PELVIC STABILIZER Ace Medical Co. | JEC |
| Mar 10, 1994 | K922796 | PELVIC C-CLAMP Synthes (Usa) | JEC |
| Feb 22, 1994 | K936124 | HOWMEDICA MONOTUBE T-CONNECTOR Howmedica, Inc. | JEC |
| Feb 22, 1994 | K936045 | ACE UNILATERAL FIXATOR II Ace Orthopedic Manufacturing Co. | JEC |
| Feb 22, 1994 | K934698 | HOWMEDICA MONO-TUBE SINGLE PIN CLAMP Howmedica Corp. | JEC |
| Feb 22, 1994 | K931578 | TEXAS SCOTTISH RITE EASY/LOCK FIXATOR Applied Osteo Systems, Inc. | JEC |
| Aug 6, 1993 | K930153 | SYSTEM III HALO RING Jerome Medical | JEC |
| Oct 6, 1992 | K920117 | HALO ESPRIT Itm Corp. | JEC |
| Apr 9, 1992 | K920149 | OSTEO EX-FI-RE Osteo AG | JEC |
| Mar 16, 1992 | K915800 | BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN Bremer Medical, Inc. | JEC |
| Nov 21, 1991 | K914858 | ACE OPEN-BACK HALO RING Ace Medical Co. | JEC |
| Sep 14, 1990 | K894959 | CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO Alphatec Mfg., Inc. | JEC |
| Sep 6, 1990 | K903105 | OLIVE K-WIRES Danek Medical, Inc. | JEC |
| Jun 21, 1990 | K901984 | ACE WIRE TENSION CLAMP Buckman Co., Inc. | JEC |
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