KWI

Product Code: KWI


Products Classified as KWI

4567Prosthesis, Elbow, Hemi-, Radial, PolymerElbow Joint Radial (hemi-elbow) Polymer Prosthesis.

Total Product Life Cycle (TPLC) Devices

4567Prosthesis, Elbow, Hemi-, Radial, PolymerElbow Joint Radial (hemi-elbow) Polymer Prosthesis.

FDA Consensus Standards

Prosthesis, Elbow, Hemi-, Radial, Polymer [37410]21 CFR §888.3170 🔎
Prosthesis, Elbow, Hemi-, Radial, Polymer [37411]21 CFR §888.3170 🔎
Prosthesis, Elbow, Hemi-, Radial, Polymer [35576]21 CFR §888.3170 🔎

Pre-market Notifications for KWI

K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes
K212872Avenger Radial Head SystemIn2Bones USA, LLC
K192754Avenger Radial Head SystemIn2Bones USA, LLC
K183618Revolution Radial HeadIgnite Orthopedics, Inc.
K172688Align Radial Head SystemSkeletal Dynamics, LLC
K132735AXIA RADIAL HEAD SYSTEMIMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME
K131845ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOCACUMED LLC
K112030SYNTHES RADIAL HEAD PROSTHESIS SYSTEMSYNTHES USA, LLC
K092721ALIGN RADIAL HEAD SYSTEMSKELETAL DYNAMICS, LLC
K062898SBI LATERAL RHEAD IMPLANTSMALL BONE INNOVATIONS INC.
K060731EVOLVE MODULAR RADIAL HEADWRIGHT MEDICAL TECHNOLOGY, INC.
K051385EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICEBIOMET, INC.
K041858ACUMED ANATOMIC RADIAL HEAD SYSTEMACUMED LLC
K040611MODULAR RADIAL HEAD REPLACEMENT DEVICEBIOMET, INC.
K032806KATALYST RADIAL HEAD IMPLANTKINETIKOS MEDICAL, INC.

Global Unique Device Identification Database

00886385025193PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025186PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025179PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025162PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025155PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025148PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025131PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025124PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025100PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025094PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025087PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025063PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025056PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025049PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
00886385025032PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Maude Adverse Events

EXPLOR 8X28MM IMPL STEM W/SCRZIMMER BIOMET, INC.2020-03-24
UNK RADIAL HEADZIMMER BIOMET, INC.2020-03-16
EXPLOR 8X28MM IMPL STEM W/SCRZIMMER BIOMET, INC.2020-03-10
UNK RADIAL HEADZIMMER BIOMET, INC.2020-03-03
ARH SLIDE-LOC? STANDARD STEM 8MMACUMED LLC2020-02-27
ARH SOLUTIONS HEAD 20MM, RIGHTACUMED LLC2020-02-27
ARH SLIDE-LOC? NECK +1MMACUMED LLC2020-02-27
EVOLVE?WRIGHT MEDICAL TECHNOLOGY, INC.2020-02-26
EXPLOR 6X24MM IMPL STEM W/SCRZIMMER BIOMET, INC.2020-02-19
IBP HMRL RIGHT SM PORBIOMET UK LTD.2020-01-31
IBP ULNA RIGHT SM INTLKBIOMET UK LTD.2020-01-31
IBP ULNA RIGHT SM INTLKBIOMET UK LTD.2020-01-30
IBP HMRL RIGHT SM PORBIOMET UK LTD.2020-01-30
PROSTHESIS, ELBOW, HEMI-, RADIAL - STEMACUMEDLLC2020-01-28
PROSTHESIS, ELBOW, HEMI-, RADIAL - STEMACUMEDLLC2020-01-28
PROSTHESIS, ELBOW, HEMI-, RADIAL - NECKACUMEDLLC2020-01-28
PROSTHESIS, ELBOW, HEMI-, RADIAL - HEADACUMEDLLC2020-01-28
PROSTHESIS, ELBOW, HEMI-, RADIAL - HEADACUMEDLLC2020-01-28
PROSTHESIS, ELBOW, HEMI-, RADIAL - NECKACUMEDLLC2020-01-28
UNK - RADIAL HEAD PROSTHESIS: RADIAL STEMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-01-16
UNK - RADIAL HEAD PROSTHESISWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-01-16
8MM TI STRAIGHT RADIAL STEM 28MM-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-01-13
26MM COCR RADIAL HEAD STANDARD HEIGHT/13.5MM-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-01-13
7MM TI STRAIGHT RADIAL STEM 26MM-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-12-16
24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-12-16
EXPLOR IMPLANT LOCKING SCREWZIMMER BIOMET, INC.2019-12-10
UNKNOWN STEMZIMMER BIOMET, INC.2019-12-10
UNKNOWN NEXEL HUMERAL COMPONENTZIMMER BIOMET, INC.2019-12-09
COONRAD MORRY HUMERAL ELBOWZIMMER BIOMET, INC.2019-11-26
UNK - RADIAL HEAD PROSTHESIS: RADIAL STEMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-19
UNK - RADIAL HEAD PROSTHESISWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-19
UNKNOWN ELBOWZIMMER BIOMET, INC.2019-11-15
UNKNOWN BIPOLAR RADIAL HEADSTRYKER GMBH2019-11-14
UNKNOWN BIPOLAR STEM IMPLANTSTRYKER GMBH2019-11-14
UNKNOWN BIPOLAR STEM IMPLANTSTRYKER GMBH2019-11-14
UNKNOWN BIPOLAR RADIAL HEADSTRYKER GMBH2019-11-14
UNKNOWN BIPOLAR STEM IMPLANTSTRYKER GMBH2019-11-14
UNKNOWN BIPOLAR RADIAL HEADSTRYKER GMBH2019-11-14
UNKNOWN STEM IMPLANTSTRYKER GMBH2019-11-13
UNKNOWN STEM IMPLANTSTRYKER GMBH2019-11-13
UNKNOWN BIPOLAR RADIAL HEADSTRYKER GMBH2019-11-13
UNKNOWN STEM IMPLANTSTRYKER GMBH2019-11-13
UNKNOWN RADIAL HEADSTRYKER GMBH2019-11-13
UNKNOWN RADIAL HEADSTRYKER GMBH2019-11-13
UNKNOWN STEM IMPLANTSTRYKER GMBH2019-11-13
UNKNOWN BIPOLAR STEM IMPLANTSTRYKER GMBH2019-11-13
UNKNOWN RADIAL HEADSTRYKER GMBH2019-11-13
UNKNOWN BIPOLAR RADIAL HEADSTRYKER GMBH2019-11-13
UNKNOWN BIPOLAR STEM IMPLANTSTRYKER GMBH2019-11-13
UNKNOWN BIPOLAR RADIAL HEADSTRYKER GMBH2019-11-13
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