JEC · Class II · 21 CFR 888.3040

FDA Product Code JEC: Component, Traction, Invasive

Leading manufacturers include Howmedica Corp., Synthes (Usa) and Howmedica Osteonics Corp..

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 Aug 24, 2007
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
K071476
Synthes (Usa)
Orthopedic · 87d
Cleared Jul 24, 2003
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Sep 23, 2002
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676
Smith & Nephew, Inc.
Orthopedic · 42d
Cleared Jul 11, 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193
Smith & Nephew, Inc.
Orthopedic · 364d
Cleared Jan 11, 2001
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 17, 1997
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
K971755
Howmedica Corp.
Orthopedic · 66d
Cleared Nov 06, 1996
MONOTUBE CARBON TUBE
K963614
Howmedica Corp.
Orthopedic · 57d
Cleared May 28, 1996
MONOTUBE TUBE TO RING CLAMP
K961618
Howmedica Corp.
Orthopedic · 32d
Cleared May 08, 1996
TITANIUM TUBE TO TUBE CLAMP
K960782
Synthes (Usa)
Orthopedic · 72d
Cleared Jan 11, 1996
MONOTUBE TUBE-TO-TUBE CLAMP
K954667
Howmedica Corp.
Orthopedic · 93d
Cleared Sep 08, 1995
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730
Howmedica Corp.
Orthopedic · 85d
Cleared Mar 10, 1994
PELVIC C-CLAMP
K922796
Synthes (Usa)
Orthopedic · 639d
Cleared Feb 22, 1994
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698
Howmedica Corp.
Orthopedic · 145d
Cleared Apr 30, 1990
SYNTHES EXTERNAL FIXATION BONE CLIP
K894098
Synthes (Usa)
Orthopedic · 325d
Cleared Aug 09, 1985
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
K852397
Howmedica Corp.
Orthopedic · 64d
Cleared Sep 11, 1984
SABA-COOMBS MINI EXTERNAL FIXATOR
K842343
Zimmer, Inc.
Orthopedic · 89d
Cleared Oct 20, 1983
OXFORD MARK 2 EXTERNAL FIXATOR
K833114
Johnson & Johnson Professionals, Inc.
Orthopedic · 37d
Cleared Jan 09, 1981
DOUBLE BALL JOINT
K803166
Howmedica Corp.
Orthopedic · 25d
Cleared Nov 19, 1980
EXTERNAL FIXATION SYSTEM
K802722
Howmedica Corp.
Orthopedic · 19d

About Product Code JEC - Regulatory Context