ClearanceBrief
Panels › Orthopedic › Product code KXE · Class 2

Prosthesis, Wrist, Hemi-, Ulnar

Regulation 888.3810

0510(k)s in 12 months (16 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
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Top companies in KXE

Decided510(k)Device and applicantCode
May 3, 2019K190599Aptis Medical Distal Radio Ulnar Joint Implant
Aptis Medical, LLC
KXE
Apr 3, 2015K142569Aptis Medical Distal Radio Ulnar Joint Implant
Aptis Medical, LLC
KXE
Apr 9, 2012K112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
Ascension Orthopedic
KXE
Nov 21, 2008K081025ISOELASTICU
Remi Sciences, Inc.
KXE
Oct 24, 2008K082839DISTAL RADIO-ULNAR JOINT IMPLANT
Aptis Medical, LLC
KXE
Jul 19, 2006K061146SBI ULNAR HEAD IMPLANT
Small Bone Innovations, Inc.
KXE
Dec 7, 2005K053119DISTAL RADIO-ULNAR JOINT IMPLANT
Aptis Medical, LLC
KXE
Nov 3, 2005K052137ASCENSION MUH
Ascension Orthopedics, Inc.
KXE
Jan 26, 2005K040497DISTAL RADIO-ULNAR JOINT IMPLANT
Aptis Medical, LLC
KXE
Dec 27, 2004K042902HERBERT ULNAR HEAD PROSTHESIS SYSTEM
Stuckenbrock Medizintechnik GmbH
KXE
Jul 28, 2004K033930KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
Kapp Surgical Instrument, Inc.
KXE
Feb 22, 2002K020274WMT MODULAR ULNAR HEAD IMPLANT
Wrightmedicaltechnologyinc
KXE
Apr 11, 2001K010786ULNAR HEAD IMPLANT
Avanta Orthopaedics, Inc.
KXE
Dec 4, 1998K982268ULNAR HEAD IMPLANT
Avanta Orthopaedics, Inc.
KXE
Aug 18, 1981K812053SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
Dow Corning Corp. Healthcare Industries Materials
KXE
Feb 8, 1979K790125ULNAR HEAD PROTHESIS
Cutter Laboratories, Inc.
KXE

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