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
85 devices
25–48 of 85
Cleared Jul 17, 1997
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
K971755
Howmedica Corp.
Orthopedic · 66d
Cleared Feb 19, 1997
STABLELOC II EXTERNAL FIXATOR
K965029
Acu Med, Inc.
Orthopedic · 64d
Cleared Nov 06, 1996
MONOTUBE CARBON TUBE
K963614
Howmedica Corp.
Orthopedic · 57d
Cleared Aug 01, 1996
HOFFMANN II CARBON CONNECTING ROD
K961916
Howmedica, Inc.
Orthopedic · 76d
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 24, 1996
EZ FIX
K954838
Biodynamic Technologies, Inc.
Orthopedic · 96d
Cleared Jan 11, 1996
MONOTUBE TUBE-TO-TUBE CLAMP
K954667
Howmedica Corp.
Orthopedic · 93d
Cleared Oct 05, 1995
EXTERNAL FIXATOR
K952330
Acu Med, Inc.
Orthopedic · 140d
Cleared Sep 08, 1995
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730
Howmedica Corp.
Orthopedic · 85d
Cleared Apr 04, 1995
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
K944092
Orthofix Srl
Orthopedic · 225d
Cleared Jan 27, 1995
EXTERNAL FIXATOR
K943857
Acu Med, Inc.
Orthopedic · 172d
Cleared Jun 16, 1994
ACE PELVIC STABILIZER
K933968
Ace Medical Co.
Orthopedic · 304d
Cleared Mar 10, 1994
PELVIC C-CLAMP
K922796
Synthes (Usa)
Orthopedic · 639d
Cleared Feb 22, 1994
TEXAS SCOTTISH RITE EASY/LOCK FIXATOR
K931578
Applied Osteo Systems, Inc.
Orthopedic · 329d
Cleared Feb 22, 1994
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698
Howmedica Corp.
Orthopedic · 145d
Cleared Feb 22, 1994
ACE UNILATERAL FIXATOR II
K936045
Ace Orthopedic Manufacturing Co.
Orthopedic · 64d
Cleared Feb 22, 1994
HOWMEDICA MONOTUBE T-CONNECTOR
K936124
Howmedica, Inc.
Orthopedic · 61d
Cleared Aug 06, 1993
SYSTEM III HALO RING
K930153
Jerome Medical
Orthopedic · 206d
Cleared Oct 06, 1992
HALO ESPRIT
K920117
Itm Corp.
Orthopedic · 267d
Cleared Apr 09, 1992
OSTEO EX-FI-RE
K920149
Osteo AG
Orthopedic · 90d
Cleared Mar 16, 1992
BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN
K915800
Bremer Medical, Inc.
Orthopedic · 83d
Cleared Nov 21, 1991
ACE OPEN-BACK HALO RING
K914858
Ace Medical Co.
Orthopedic · 23d
Cleared Sep 14, 1990
CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO
K894959
Alphatec Mfg., Inc.
Orthopedic · 403d