Atlas FDA

KXE

16 FDA 510(k) clearances · Product code

85 daysmedian time to decision
225 days90th percentile
16clearances measured

FDA profile

Official device name
Prosthesis, Wrist, Hemi-, Ulnar
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3810
Medical specialty
Orthopedic
Flags
Implant
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RecordFirmDate
Aptis Medical Distal Radio Ulnar Joint Implant (K190599)Aptis Medical, LLC2019-05-03
Aptis Medical Distal Radio Ulnar Joint Implant (K142569)Aptis Medical, LLC2015-04-03
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (K112481)Ascension Orthopedic2012-04-09
ISOELASTICU (K081025)Remi Sciences, Inc.2008-11-21
DISTAL RADIO-ULNAR JOINT IMPLANT (K082839)Aptis Medical, LLC2008-10-24
SBI ULNAR HEAD IMPLANT (K061146)Small Bone Innovations, Inc.2006-07-19
DISTAL RADIO-ULNAR JOINT IMPLANT (K053119)Aptis Medical, LLC2005-12-07
ASCENSION MUH (K052137)Ascension Orthopedics, Inc.2005-11-03
DISTAL RADIO-ULNAR JOINT IMPLANT (K040497)Aptis Medical, LLC2005-01-26
HERBERT ULNAR HEAD PROSTHESIS SYSTEM (K042902)Stuckenbrock Medizintechnik GmbH2004-12-27
KAPP CUSTOM ULNAR HEAD WRIST IMPLANT (K033930)Kapp Surgical Instrument, Inc.2004-07-28
WMT MODULAR ULNAR HEAD IMPLANT (K020274)Wrightmedicaltechnologyinc2002-02-22
ULNAR HEAD IMPLANT (K010786)Avanta Orthopaedics, Inc.2001-04-11
ULNAR HEAD IMPLANT (K982268)Avanta Orthopaedics, Inc.1998-12-04
SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) (K812053)Dow Corning Corp. Healthcare Industries Materials1981-08-18
ULNAR HEAD PROTHESIS (K790125)Cutter Laboratories, Inc.1979-02-08

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Every clearance here is in the API, with alerts when new ones post.