LXT · Class II · 21 CFR 888.3030

FDA Product Code LXT: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

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

57
Total
57
Cleared
73d
Avg days
1986
Since
57 devices
25–48 of 57
Cleared Apr 01, 2003
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
K030390
Synthes (Usa)
Orthopedic · 55d
Cleared Oct 17, 2002
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
K022651
Howmedica Osteonics Corp.
Orthopedic · 69d
Cleared Apr 15, 2002
NBX - NON-BRIDGING EXTERNAL FIXATOR
K020905
Biomet Orthopedics, Inc.
Orthopedic · 26d
Cleared Dec 13, 2001
MODIFICATION TO EBI XFIX DFS SYSTEM
K013739
Ebi, L.P.
Orthopedic · 30d
Cleared Dec 03, 2001
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K013772
Howmedica Osteonics
Orthopedic · 20d
Cleared Jul 13, 2001
HOFFMAN II HYBRID RING CLAMP
K011948
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Dec 29, 2000
BIOMET EXTERNAL WRIST PLATE
K003240
Biomet, Inc.
Orthopedic · 73d
Cleared Dec 18, 2000
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
K002923
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 15, 2000
TRANSFX ANGLED RODS
K003205
Immedica, Inc.
Orthopedic · 63d
Cleared Dec 15, 2000
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
K003211
Howmedica Osteonics Corp.
Orthopedic · 63d
Cleared Aug 31, 2000
RADIOLUCENT COLLES FRACTURE KIT
K001760
Biomet, Inc.
Orthopedic · 83d
Cleared Aug 17, 2000
SYNTHES SCALLOPED DISTAL TIBIA PLATE
K001793
Synthes (Usa)
Orthopedic · 64d
Cleared Jun 16, 2000
SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
K000972
Synthes (Usa)
Orthopedic · 81d
Cleared Jun 15, 2000
TRANS FX ADJUSTABLE PIN TO BAR CLAMP
K001084
Immedica, Inc.
Orthopedic · 72d
Cleared May 23, 2000
HOFFMANN II EXTERNAL FIXATION SYSTEM
K000957
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Apr 14, 2000
SYNTHES (USA) WRIST FUSION PLATES (WFP)
K000558
Synthes (Usa)
Orthopedic · 56d
Cleared Aug 12, 1999
ULTIMAX HAIG II NAIL SYSTEM
K991889
Encore Orthopedics, Inc.
Orthopedic · 70d
Cleared Jul 22, 1999
TRANSFX MULTI PIN CLAMP
K991723
Immedica, Inc.
Orthopedic · 63d
Cleared Jun 11, 1999
SYNTHES LOCKING CALCANEAL PLATES
K991407
Synthes (Usa)
Orthopedic · 50d
Cleared May 17, 1999
TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
K990848
Immedica, Inc.
Orthopedic · 63d
Cleared Mar 04, 1999
TRANSFX EXTERNAL FIXATION SYSTEM
K984357
Immedica, Inc.
Orthopedic · 87d
Cleared May 22, 1998
DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI
K974245
Depuy Ace Medical Co.
Orthopedic · 191d
Cleared Nov 13, 1996
GUIDE WIRES FOR CANNULATED SCREWS
K963432
Orthopaedic Biosystems, Ltd.
Orthopedic · 75d
Cleared Nov 12, 1996
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
K963618
Synthes (Usa)
Orthopedic · 63d