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
49–57 of 57
Cleared Oct 23, 1996
EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
K962846
Biodynamic Technologies, Inc.
Orthopedic · 93d
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 Jan 31, 1996
ACE-DUPONT COMPOSITE RINGS
K955388
Ace Medical Co.
Orthopedic · 68d
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 Oct 03, 1994
TRUE/LOK MONOLATERAL/BILATERAL FIXATOR
K941048
Applied Osteo Systems, Inc.
Orthopedic · 210d
Cleared May 20, 1988
ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY
K874377
Harrington Arthritis Research Center
Orthopedic · 207d
Cleared Dec 18, 1986
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
K864403
Howmedica Corp.
Orthopedic · 38d