KWL

Product Code: KWL


Products Classified as KWL

4570Prosthesis, Hip, Hemi-, Femoral, MetalHip Joint Femoral (hemi-hip) Metallic Cemented Or Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4570Prosthesis, Hip, Hemi-, Femoral, MetalHip Joint Femoral (hemi-hip) Metallic Cemented Or Uncemented Prosthesis.

FDA Consensus Standards

Prosthesis, Hip, Hemi-, Femoral, Metal [37410]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [37411]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [33949]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [34694]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [32390]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [34715]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [31881]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [31882]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [33110]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [31898]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [38311]21 CFR §888.3360 🔎
Prosthesis, Hip, Hemi-, Femoral, Metal [38310]21 CFR §888.3360 🔎

Pre-market Notifications for KWL

K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics
K192995OsteoRemedies Hip Spacer SystemOsteoRemedies, LLC
K191981REMEDY Acetabular CupOsteoRemedies, LLC
K173967Remedy Acetabular CupOsteoremedies LLC
K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoRemedies, LLC
K143184Evolve UniPolar HeadSignature Orthopaedics Pty Ltd.
K1124702GC HIP/KNEE MODULAR SPACERMANDELL HORWITZ CONSULTANTS LLC
K111911CORIN OPTIMOM MODULAR HEADCORIN U.S.A.
K071471CORIN ADAPTOR SLEEVEHOWMEDICA OSTEONICS CORP
K063791CORIN UNIPOLAR MODULAR HEADCORIN USA
K062408SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEADSMITH & NEPHEW, INC.
K062273SPACER-G TEMPORARY HIP PROSTHESISTECRES SPA
K061243SMITH & NEPHEW MODULAR FEMORAL HEADSMITH & NEPHEW, INC.
K042973SOLITUDE UNIPOLAR HEADORTHO DEVELOPMENT CORP.
K031841SPACER G TEMPORARY HIP PROSTHESISEXACTECH, INC.

Global Unique Device Identification Database

00814193025647Prosthesis, Hip, Hemi-, Femoral, Metal
00814193024831Prosthesis, Hip, Hemi-, Femoral, Metal
00814193024824Prosthesis, Hip, Hemi-, Femoral, Metal
00814193024817Prosthesis, Hip, Hemi-, Femoral, Metal
00814193024800Prosthesis, Hip, Hemi-, Femoral, Metal
00814193024794Prosthesis, Hip, Hemi-, Femoral, Metal
00814193024787Prosthesis, Hip, Hemi-, Femoral, Metal
00814193024770Prosthesis, Hip, Hemi-, Femoral, Metal
00814193024763Prosthesis, Hip, Hemi-, Femoral, Metal
00814193023681Prosthesis, Hip, Hemi-, Femoral, Metal
00814193023674Prosthesis, Hip, Hemi-, Femoral, Metal
00814193023667Prosthesis, Hip, Hemi-, Femoral, Metal
00814193023650Prosthesis, Hip, Hemi-, Femoral, Metal
00814193023643Prosthesis, Hip, Hemi-, Femoral, Metal
00814193023636Prosthesis, Hip, Hemi-, Femoral, Metal

Maude Adverse Events

ACTIS BROACH SZ 7DEPUY IRELAND - 96166712020-03-31
FITMORE STEMZIMMER GMBH2020-03-31
ACTIS BROACH SZ 4DEPUY IRELAND - 96166712020-03-30
ACTIS BROACH SZ 3DEPUY IRELAND - 96166712020-03-25
ACTIS COLLARED HIGH SIZE 6DEPUY ORTHOPAEDICS INC US2020-03-23
STRYKER METAL-ON-METAL HIP IMPLANTSTRYKER/HOWMEDICA OSTEONICS CORP2020-03-19
UNKNOWN DISTAL FEMORAL REPLACEMENTSTANMORE IMPLANTS WORLDWIDE2020-03-19
TRI-LOCK TI 11.3 STD OFFSETDEPUY ORTHOPAEDICS INC US2020-03-18
ACTIS RETAINING STEM INSERTERDEPUY IRELAND - 96166712020-03-18
ACTIS BROACH STARTERDEPUY IRELAND - 96166712020-03-18
ACTIS BROACH SZ 6DEPUY IRELAND - 96166712020-03-17
ACTIS BROACH SZ 1DEPUY IRELAND - 96166712020-03-16
TRI-LOCK TI 15.0 LAT OFFSETDEPUY ORTHOPAEDICS INC US2020-03-16
TRI-LOCK TI 15.0 LAT OFFSETDEPUY ORTHOPAEDICS INC US2020-03-16
ACTIS BROACH SZ 5DEPUY IRELAND - 96166712020-03-13
ACTIS BROACH SZ 7DEPUY IRELAND - 96166712020-03-13
ACTIS BROACH SZ 5DEPUY IRELAND - 96166712020-03-13
ACTIS BROACH SZ 7DEPUY IRELAND - 96166712020-03-13
ACTIS BROACH SZ 8DEPUY IRELAND - 96166712020-03-13
ACTIS BROACH SZ 8DEPUY IRELAND - 96166712020-03-13
UNIPOLAR HIPENCORE MEDICAL L.P.2020-03-13
ACTIS BROACH SZ 1DEPUY IRELAND - 96166712020-03-10
ACTIS BROACH SZ 1DEPUY ORTHOPAEDICS INC US2020-03-10
UNKNOWN POLYETHYLENE BEARINGSTRYKER GMBH2020-03-09
ACTIS BROACH SZ 5DEPUY IRELAND - 96166712020-03-09
UNKNOWN POLYETHYLENE BEARINGSTRYKER GMBH2020-03-09
UNKNOWN POLYETHYLENE BEARINGSTRYKER GMBH2020-03-09
UNKNOWN POLYETHYLENE BEARINGSTRYKER GMBH2020-03-06
UNKNOWN POLYETHYLENE BEARINGSTRYKER GMBH2020-03-06
UNKNOWN POLYETHYLENE BEARINGSTRYKER GMBH2020-03-06
ACTIS COLLARED HIGH SIZE 10DEPUY IRELAND - 96166712020-03-06
ACTIS STRAIGHT INSERTER SHAFTDEPUY IRELAND - 96166712020-03-06
ACTIS COLLARED STD SIZE 5DEPUY IRELAND - 96166712020-03-04
UNKNOWN POLYETHYLENE BEARINGSTRYKER GMBH2020-03-04
ACTIS COLLARED STD SIZE 6DEPUY IRELAND - 96166712020-03-03
ACTIS BROACH SZ 4DEPUY IRELAND - 96166712020-03-02
TAPERLOC COMPLETE PPS TYPE 1ZIMMER BIOMET, INC.2020-03-02
ACTIS RETAINING STEM INSERTERDEPUY IRELAND - 96166712020-02-28
ACTIS BROACH SZ 4DEPUY IRELAND - 96166712020-02-27
ACTIS COLLARED HIGH SIZE 4DEPUY IRELAND - 96166712020-02-25
ACTIS BROACH SZ 6DEPUY IRELAND - 96166712020-02-25
ACTIS COLLARED STD SIZE 4DEPUY IRELAND - 96166712020-02-25
ACTIS BROACH SZ 5DEPUY ORTHOPAEDICS INC US2020-02-24
ACTIS COLLARED STD SIZE 6DEPUY IRELAND - 96166712020-02-21
UHR BIPOLAR 26X54MMSTRYKER ORTHOPAEDICS-MAHWAH2020-02-19
ACTIS BROACH SZ 5DEPUY IRELAND - 96166712020-02-14
ACTIS COLLARED STD SIZE 2DEPUY IRELAND - 96166712020-02-13
ACTIS COLLARED HIGH SIZE 7DEPUY IRELAND - 96166712020-02-13
ACTIS COLLARED STD SIZE 8DEPUY IRELAND - 96166712020-02-13
ACTIS COLLARED STD SIZE 5DEPUY IRELAND - 96166712020-02-11
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