JEC · Class II · 21 CFR 888.3040

FDA Product Code JEC: Component, Traction, Invasive

Leading manufacturers include Howmedica Corp., Ace Orthopedic Manufacturing Co. and Synthes (Usa).

85
Total
85
Cleared
96d
Avg days
1976
Since

FDA 510(k) Cleared Component, Traction, Invasive Devices (Product Code JEC)

85 devices
1–24 of 85
Cleared Apr 23, 2021
SteriTrak
K203605
Arbutus Medical, Inc.
Orthopedic · 134d
Cleared Mar 02, 2020
Anjon Bremer Halo System
K193256
Anjon Holdings, LLC
Orthopedic · 97d
Cleared Oct 10, 2019
DigiFix Sterile Kit
K192465
Virak Orthopedics, LLC
Orthopedic · 31d
Cleared Oct 22, 2018
PIP Fix
K181192
Hand Biomechanics Lab, Inc.
Orthopedic · 171d
Cleared Mar 19, 2018
Anjon Bremer Halo System
K171863
Anjon Holdings, LLC
Orthopedic · 270d
Cleared Dec 28, 2016
Medline ReNewal Reprocessed Stryker External Fixation Devices
K163028
Surgical Instrument Service and Savings, Inc.
Orthopedic · 58d
Cleared Jan 10, 2014
DIGIFIX EXTERNAL FIXATION SYSTEM
K132731
Virak Orthopedic Research, LLC
Orthopedic · 129d
Cleared Jan 14, 2011
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
K102885
Stryker Corp.
Orthopedic · 106d
Cleared Apr 07, 2009
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
K082679
Sintea Biotech, Inc.
Orthopedic · 204d
Cleared Jan 09, 2008
F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
K072432
Hand Biomechanics Lab, Inc.
Orthopedic · 133d
Cleared Aug 24, 2007
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
K071476
Synthes (Usa)
Orthopedic · 87d
Cleared Aug 25, 2004
KLSA MARTIN HAND DISTRACTOR
K042066
KLS-Martin L.P.
Orthopedic · 23d
Cleared Oct 09, 2003
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
K032427
Meridan Medical
Orthopedic · 64d
Cleared Jul 24, 2003
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jun 10, 2003
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
K030519
Hand Biomechanics Lab, Inc.
Orthopedic · 111d
Cleared Sep 23, 2002
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676
Smith & Nephew, Inc.
Orthopedic · 42d
Cleared Aug 06, 2002
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
K022065
Sintea Biotech, Inc.
Orthopedic · 42d
Cleared Jul 11, 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193
Smith & Nephew, Inc.
Orthopedic · 364d
Cleared Dec 05, 2001
AUTOGENESIS AUTOMATOR, MODEL M1000
K013818
Autogenesis, Inc.
Orthopedic · 19d
Cleared Jan 11, 2001
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 15, 1999
BREMER HALO SYSTEM TITANIUM SKULL PIN
K993099
Depuyacromed
Orthopedic · 90d
Cleared May 21, 1999
CENTRAFIX EXTERNAL FIXATOR
K991732
Owandar Medical, Ltd.
Orthopedic
Cleared Feb 12, 1999
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
K984442
Hand Biomechanics Lab, Inc.
Orthopedic · 60d
Cleared May 20, 1998
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
K981423
Autogenesis, Inc.
Orthopedic · 30d

About Product Code JEC - Regulatory Context