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KXE — Prosthesis, Wrist, Hemi-, Ulnar Class II

FDA Device Classification

Classification Details

Product Code
KXE
Device Class
Class II
Regulation Number
888.3810
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K190599aptis medicalAptis Medical Distal Radio Ulnar Joint ImplantMay 3, 2019
K142569aptis medicalAptis Medical Distal Radio Ulnar Joint ImplantApril 3, 2015
K112481ascension orthopedicFIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTApril 9, 2012
K081025remi sciencesISOELASTICUNovember 21, 2008
K082839aptis medicalDISTAL RADIO-ULNAR JOINT IMPLANTOctober 24, 2008
K061146small bone innovationsSBI ULNAR HEAD IMPLANTJuly 19, 2006
K053119aptis medicalDISTAL RADIO-ULNAR JOINT IMPLANTDecember 7, 2005
K052137ascension orthopedicsASCENSION MUHNovember 3, 2005
K040497aptis medicalDISTAL RADIO-ULNAR JOINT IMPLANTJanuary 26, 2005
K042902stuckenbrock medizintechnikHERBERT ULNAR HEAD PROSTHESIS SYSTEMDecember 27, 2004
K033930kapp surgical instrumentKAPP CUSTOM ULNAR HEAD WRIST IMPLANTJuly 28, 2004
K020274wrightmedicaltechnologyincWMT MODULAR ULNAR HEAD IMPLANTFebruary 22, 2002
K010786avanta orthopaedicsULNAR HEAD IMPLANTApril 11, 2001
K982268avanta orthopaedicsULNAR HEAD IMPLANTDecember 4, 1998
K812053dow corning corp. healthcare industries materialsSILASTIC HEMI WRIST IMPLANT H.P. (RAD.)August 18, 1981
K790125cutter laboratoriesULNAR HEAD PROTHESISFebruary 8, 1979