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 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 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 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
Cleared Nov 19, 1980
EXTERNAL FIXATION SYSTEM
K802722
Howmedica Corp.
Orthopedic · 19d
Cleared Nov 19, 1980
EXTENDED BALLJOINT GRIP
K802723
Howmedica Corp.
Orthopedic · 19d
Cleared Nov 19, 1980
HOFFMAN LEG LENGTHENING DEVICE
K802776
Howmedica Corp.
Orthopedic · 14d
Cleared Feb 11, 1980
OXFORD EXTERNAL FIXATION SYSTEM
K800184
Downs Surgical , Ltd.
Orthopedic · 13d
Cleared Feb 13, 1979
UNIVERSAL EXTERNAL FIXATION ASSEMBLY
K790262
Zimmer, Inc.
Orthopedic · 7d
Cleared Dec 17, 1976
DEPUY MODIFIED SKELETAL TRACTION PIN
K761088
Depuy, Inc.
Orthopedic · 25d