JEC · Class II · 21 CFR 888.3040

FDA Product Code JEC: Component, Traction, Invasive

Leading manufacturers include Howmedica Corp., Ace Orthopedic Manufacturing Co. and Hand Biomechanics Lab, Inc..

85
Total
85
Cleared
96d
Avg days
1976
Since
85 devices
49–72 of 85
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 Aug 11, 1989
TRACER DYNAMIC AXIAL FIXATION
K892638
Tracer Medical
Orthopedic · 121d
Cleared Feb 10, 1989
AME PINSITE SHIELD(TM)
K884798
American Medical Electronics, Inc.
Orthopedic · 86d
Cleared Dec 29, 1988
MODIFIED CHICK AMBULATORY HALO
K884242
Chick Medical Products
Orthopedic · 79d
Cleared Sep 30, 1988
JMS CERVICAL TRACTION DEVICE/HALO DEVICE
K882877
Jerome Medical
Orthopedic · 81d
Cleared Jul 28, 1988
KIRSCHNER SUPER-FIXATION SYSTEM
K881896
Kirschner Medical Corp.
Orthopedic · 84d
Cleared Jun 03, 1988
LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER
K881673
Lima-Lto, Inc.
Orthopedic · 46d
Cleared Feb 18, 1988
LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
K880282
Lima-Lto, Inc.
Orthopedic · 28d
Cleared Jul 10, 1987
VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS
K872538
Vitaphore Corp.
Orthopedic · 11d
Cleared Aug 09, 1985
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
K852397
Howmedica Corp.
Orthopedic · 64d
Cleared Feb 13, 1985
AGEE EXTERNAL FIXATOR
K842493
The Hand Biomechanics Research Laboratory
Orthopedic · 232d
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 Apr 25, 1984
MODULAR CONSTRUCT FRAME EXTERNAL FIXA
K840856
Precision Medical Devices, Inc.
Orthopedic · 61d
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 Oct 06, 1982
CERVICAL BRACE
K822780
Jerome Medical
Orthopedic · 22d
Cleared Jan 09, 1981
DOUBLE BALL JOINT
K803166
Howmedica Corp.
Orthopedic · 25d
Cleared Dec 10, 1980
ORTHOFIX AXIALEXTERNAL FIXATION SYS.
K802814
Cintor Orthopaedic Div.
Orthopedic · 33d
Cleared Nov 19, 1980
EXTERNAL FIXATION SYSTEM
K802722
Howmedica Corp.
Orthopedic · 19d