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LXT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Class II

FDA Device Classification

Classification Details

Product Code
LXT
Device Class
Class II
Regulation Number
888.3030
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230067new paradigm biomedicalPara-Fix External Fixation SystemSeptember 22, 2023
K131636acumedPOLARUS CONNECTOctober 10, 2013
K132704biometDISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWOctober 9, 2013
K112345medos international sarlDISTAL VOLAR RADIUS PLATING SYSTEMSOctober 31, 2011
K090374depuy orthopaedicsSTERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 March 11, 2009
K073135synthes (usa)SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONSJanuary 29, 2008
K063832synthes (usa)SYNTHES (USA) ELBOW HINGE FIXATORMarch 7, 2007
K060864hand innovationsMULTIDIRECTIONAL THREADED PEGApril 28, 2006
K060403meridian medicalPTA (PROGRESSIVE TIBIAL ALIGNMENT)March 28, 2006
K060290hand innovationsSHOULDER FIXATION SYSTEMFebruary 27, 2006
K052754dvo extremity solutionsWRIST FUSION PLATEOctober 27, 2005
K051728hand innovationsMODIFICATION TO SHOULDER FIXATION SYSTEMJuly 20, 2005
K051306howmedica osteonicsHOFFMANN II MRI EXTERNAL FIXATION SYSTEMJune 17, 2005
K050932hand innovationsDISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEMApril 26, 2005
K050631synthes (usa)SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSIONApril 11, 2005
K042458a.m. surgicalA.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEMOctober 7, 2004
K042059hand innovationsSHOULDER FIXATION SYSTEMSeptember 30, 2004
K033805synthes (usa)SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATESFebruary 20, 2004
K033145howmedica osteonicsHOFFMANN II PELVIC CLAMPNovember 5, 2003
K032705hand innovationsDISTAL RADIUS FRACTURE REPAIR SYSTEMOctober 1, 2003