JEC · Class II · 21 CFR 888.3040

FDA Product Code JEC: Component, Traction, Invasive

Leading manufacturers include Howmedica Corp., Synthes (Usa) and Acu Med, Inc..

85
Total
85
Cleared
96d
Avg days
1976
Since
85 devices
25–48 of 85
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
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698
Howmedica Corp.
Orthopedic · 145d
Cleared Feb 22, 1994
HOWMEDICA MONOTUBE T-CONNECTOR
K936124
Howmedica, Inc.
Orthopedic · 61d
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
Cleared Sep 06, 1990
OLIVE K-WIRES
K903105
Danek Medical, Inc.
Orthopedic · 63d
Cleared Jun 21, 1990
ACE WIRE TENSION CLAMP
K901984
Buckman Co., Inc.
Orthopedic · 50d
Cleared Apr 30, 1990
SYNTHES EXTERNAL FIXATION BONE CLIP
K894098
Synthes (Usa)
Orthopedic · 325d
Cleared Jan 11, 1990
ACE WIRE TENSION CLAMP
K894982
Buckman Co., Inc.
Orthopedic · 156d
Cleared Jul 28, 1988
KIRSCHNER SUPER-FIXATION SYSTEM
K881896
Kirschner Medical Corp.
Orthopedic · 84d
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 May 16, 1984
RICHARDS FIXATOR SYSTEM
K841334
Richards Medical Co., Inc.
Orthopedic · 44d
Cleared Oct 20, 1983
OXFORD MARK 2 EXTERNAL FIXATOR
K833114
Johnson & Johnson Professionals, Inc.
Orthopedic · 37d
Cleared Jun 08, 1983
ORTHOFIX
K831576
Electro-Biology, Inc.
Orthopedic · 23d
Cleared Feb 02, 1983
COLLES FRACTURE FRAME
K830154
Richard'S Medical Equip., Inc.
Orthopedic · 15d
Cleared Jan 09, 1981
DOUBLE BALL JOINT
K803166
Howmedica Corp.
Orthopedic · 25d