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 Biomet, Inc..

57
Total
57
Cleared
73d
Avg days
1986
Since
57 devices
25–48 of 57
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 Jun 11, 1999
SYNTHES LOCKING CALCANEAL PLATES
K991407
Synthes (Usa)
Orthopedic · 50d
Cleared Nov 12, 1996
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
K963618
Synthes (Usa)
Orthopedic · 63d
Cleared May 16, 1996
BERLIN EXTERNAL FIXATOR
K954053
Encore Orthopedics, Inc.
Orthopedic · 261d
Cleared Apr 04, 1996
TITANIUM UNIVERSAL CLAMP
K960269
Synthes (Usa)
Orthopedic · 77d
Cleared Oct 31, 1995
HEX-FIX FIELD FIXATOR
K953397
Smith & Nephew Richards, Inc.
Orthopedic · 103d
Cleared May 22, 1995
SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
K950384
Synthes (Usa)
Orthopedic · 110d
Cleared Dec 18, 1986
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
K864403
Howmedica Corp.
Orthopedic · 38d