Product Code: KXE


Products Classified as KXE

4585Prosthesis, Wrist, Hemi-, UlnarWrist Joint Ulnar (hemi-wrist) Polymer Prosthesis.

Total Product Life Cycle (TPLC) Devices

4585Prosthesis, Wrist, Hemi-, UlnarWrist Joint Ulnar (hemi-wrist) Polymer Prosthesis.

FDA Consensus Standards

Prosthesis, Wrist, Hemi-, Ulnar [34059]21 CFR §888.3810 🔎
Prosthesis, Wrist, Hemi-, Ulnar [38231]21 CFR §888.3810 🔎
Prosthesis, Wrist, Hemi-, Ulnar [37410]21 CFR §888.3810 🔎
Prosthesis, Wrist, Hemi-, Ulnar [37411]21 CFR §888.3810 🔎
Prosthesis, Wrist, Hemi-, Ulnar [33508]21 CFR §888.3810 🔎
Prosthesis, Wrist, Hemi-, Ulnar [32210]21 CFR §888.3810 🔎
Prosthesis, Wrist, Hemi-, Ulnar [32380]21 CFR §888.3810 🔎
Prosthesis, Wrist, Hemi-, Ulnar [33509]21 CFR §888.3810 🔎
Prosthesis, Wrist, Hemi-, Ulnar [32381]21 CFR §888.3810 🔎

Pre-market Notifications for KXE

K190599Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLC
K142569Aptis Medical Distal Radio Ulnar Joint ImplantAPTIS MEDICAL, LLC.
K112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTASCENSION ORTHOPEDIC
K082839DISTAL RADIO-ULNAR JOINT IMPLANTAPTIS MEDICAL, LLC.
K061146SBI ULNAR HEAD IMPLANTSMALL BONE INNOVATIONS INC.
K053119DISTAL RADIO-ULNAR JOINT IMPLANTAPTIS MEDICAL, LLC.
K052137ASCENSION MUHASCENSION ORTHOPEDICS, INC.
K042902HERBERT ULNAR HEAD PROSTHESIS SYSTEMSTUCKENBROCK MEDIZINTECHNIK GMBH
K040497DISTAL RADIO-ULNAR JOINT IMPLANTAPTIS MEDICAL, LLC.
K033930KAPP CUSTOM ULNAR HEAD WRIST IMPLANTKAPP SURGICAL INSTRUMENT, INC.
K020274WMT MODULAR ULNAR HEAD IMPLANTWRIGHT MEDICAL TECHNOLOGY, INC.
K010786ULNAR HEAD IMPLANTAVANTA ORTHOPAEDICS, INC.
K982268ULNAR HEAD IMPLANTAVANTA ORTHOPAEDICS, INC.
K812053SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K790125ULNAR HEAD PROTHESISCUTTER LABORATORIES, INC.

Global Unique Device Identification Database

00886385022611PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022604PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022598PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022581PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022574PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022567PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022550PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022543PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022536PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022529PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022499PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022451PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022444PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022437PROSTHESIS, WRIST, HEMI-, ULNAR
00886385022420PROSTHESIS, WRIST, HEMI-, ULNAR

Maude Adverse Events

UNKNOWN MOOVIS METACARPAL STEMSTRYKER GMBH2019-08-23
UNKNOWN MOOVIS METACARPAL STEMSTRYKER GMBH2019-08-23
UNKNOWN MOOVIS METACARPAL STEMSTRYKER GMBH2019-08-22
UNKNOWN REMOTION WRIST CARPAL SCREW IMPLANTSTRYKER GMBH2019-03-08
UNKNOWN REMOTION WRIST RADIAL IMPLANTSTRYKER GMBH2019-03-07
UNKNOWN REMOTION WRIST RADIAL IMPLANTSTRYKER GMBH2019-03-07
UNKNOWN REMOTION TOTAL WRIST RADIAL IMPLANTSTRYKER GMBH2019-03-07
ULNAR SCREWZIMMER BIOMET, INC.2018-12-20
ULNAR COMPONENTZIMMER BIOMET, INC.2018-02-22
APTIS DRUJAPTIS MEDICAL2018-02-13
UNKNOWN SMOOTH PEGZIMMER BIOMET, INC.2017-11-02
UNKNOWN ULNAR STEMZIMMER BIOMET, INC.2017-11-02
UNKNOWN NEXEL PROXIMAL ULNAZIMMER BIOMET, INC.2017-10-26
UNKNOWN ULNAR STEMZIMMER BIOMET, INC.2017-09-21
UNKNOWN ULNARZIMMER, INC.2017-09-06
UNKNOWN WRIST PLATESTRYKER GMBH2016-12-19
UNKNOWN EXTREMITYBIOMET ORTHOPEDICS2016-06-08
UHEAD STEMSTRYKER GMBH2016-05-09
RECON ULNAR STEM IMPLANT #2, 20MM EXTENSIONSTRYKER GMBH2015-12-22
RECON ULNAR STEM IMPLANT #3, 20MM EXTENSIONSTRYKER GMBH2015-12-22
RECON ULNAR STEM IMPLANT #2, 20MM EXTENSIONSTRYKER GMBH2015-12-21
MUH STEM SZZ. 5.5 SASCENSION ORTHOPEDICS2014-09-15
MUH STEM SZ. 4.5 SASCENSION ORTHOPEDICS2014-09-15
MUH HEAD SZ. 19.0ASCENSION ORTHOPEDICS2014-09-15
FIRST CHOICE HEAD 16.0-STEM 5.5ASCENSION ORTHOPEDICS2013-06-14
UNKNOWN_RECONSTRUCTIVE_PRODUCTSTRYKER ORTHOPAEDICS-MAHWAH2013-05-20
FIRST CHOICE HEAD 14.5-STEM 5.5ASCENSION ORTHOPEDICS2011-12-06
ASCENSION DRUJASCENSION ORTHOPEDICS, INC.2011-07-01
ASCENSION DRUJASCENSION ORTHOPEDICS, INC.2011-07-01
SIGMOID NOTCHSMALL BONE INNOVATIONS, INC.2011-06-17
RE-MOTIONSMALL BONE INNOVATIONS2010-11-08
DISTAL RADIOULNAR JOINT ASSEMBLYAPTIS MEDICAL, LLC.2009-03-16
DISTAL RADIOULNAR JOINT PLATE ASSEMBLYAPTIS MEDICAL, LLC.2009-02-18
E-CENTRIX ULNAR HEADWRIGHT MEDICAL TECHNOLOGY, INC.2008-05-23
CUSTOM RIGHT ULNAR COMPSTRYKER ORTHOPAEDICS MAHWAH2008-01-09
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