KWY

Product Code: KWY


Products Classified as KWY

4579Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or UncementedHip Joint Femoral (hemi-hip) Metal/polymer Cemented Or Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4579Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or UncementedHip Joint Femoral (hemi-hip) Metal/polymer Cemented Or Uncemented Prosthesis.

FDA Consensus Standards

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [34059]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [38231]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [37410]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [37411]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [33508]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [32210]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [32380]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [33509]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [33949]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [32381]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [34694]21 CFR §888.3390 ๐Ÿ”Ž
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented [32390]21 CFR §888.3390 ๐Ÿ”Ž

Pre-market Notifications for KWY

K220492COPAL Exchange G Hip SpacerHeraeus Medical GmbH
K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.
K192236Fitmore Hip StemZimmer GmbH
K191569Implantcast Ic-Bipolar Head SystemImplantcast, GmbH
K191297INSitu Bipolar Hip SystemTheken Companies, LLC
K191016COPAL Exchange G Hip And Knee SpacersHeraeus Medical GmbH
K183114Corin BiPolar-iCorin USA Limited
K180130ELEOSโ„ข Bipolar Acetabular SystemOnkos Surgical, Inc.
K173455SurgTech Bipolar Head SystemSurgTech, Inc.,
K170072Fitmoreยฎ Hip StemZimmer GmbH
K16308140-42mm BiPolar Head And 22mm Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTD.
K152439U2 Bipolar Implant And 22mm Femoral HeadUNITED ORTHOPEDIC CORPORATION
K143113Klassic BiPolar SystemTotal Joint Orthopedics
K132539RING-LOK MODULAR BIPOLAR SYSTEMIMPLANTS INTERNATIONAL, LTD
K131354RENOVIS BIPOLAR HIP SYSTEMRENOVIS SURGICAL TECHNOLOGIES LLC

Global Unique Device Identification Database

00814703012198Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012181Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012174Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012167Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012150Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012143Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012136Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012129Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012112Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012105Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012099Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012082Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012075Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012068Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
00814703012051Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Maude Adverse Events

UNKNOWN HIP FEMORAL STEMDEPUY ORTHOPAEDICS INC US2020-03-31
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-31
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-31
UNKNOWN HIP CONSTRAINED ACETABULAR LINERSDEPUY ORTHOPAEDICS INC US2020-03-30
SELF CNTR HIP 43X22.225 GRYDEPUY ORTHOPAEDICS INC US2020-03-30
UNKNOWN HIP FEMORAL STEMDEPUY ORTHOPAEDICS INC US2020-03-30
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-30
UNKNOWN HIP FEMORAL STEMDEPUY ORTHOPAEDICS INC US2020-03-30
BIPOLAR PROSTHESIS 43/28SMITH & NEPHEW ORTHOPAEDICS AG2020-03-27
HIP BA BIO 28MM 12/14 + 5DEPUY INTERNATIONAL LTD - 80103792020-03-27
UNKNOWN M2A MAGNUM HEADZIMMER BIOMET, INC.2020-03-27
UNKNOWN HIP ACETABULAR LINERSDEPUY ORTHOPAEDICS INC US2020-03-26
OMNI HIP SYSTEMOMNILIFE SCIENCE INC.2020-03-26
UNKNOWN HIP FEMORAL STEMDEPUY ORTHOPAEDICS INC US2020-03-26
UNKNOWN HIP ACETABULAR LINERSDEPUY ORTHOPAEDICS INC US2020-03-26
UNKNOWN HIP FEMORAL STEMDEPUY ORTHOPAEDICS INC US2020-03-26
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-26
UNKNOWN HIP ACETABULAR LINERSDEPUY ORTHOPAEDICS INC US2020-03-26
UNKNOWN HIP ACETABULAR LINERSDEPUY ORTHOPAEDICS INC US2020-03-26
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-26
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-26
RINGLOC BI-POLAR 28X49MMZIMMER BIOMET, INC.2020-03-26
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-26
UNKNOWN HIP ACETABULAR LINERSDEPUY ORTHOPAEDICS INC US2020-03-26
UNKNOWN LONGEVITY POLYETHYLENE LINERZIMMER BIOMET, INC.2020-03-26
OMNI HIP SYSTEMOMNILIFE SCIENCE INC.2020-03-25
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-25
SHELL 47 MM O.D.ZIMMER MANUFACTURING B.V.2020-03-25
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-25
UNKNOWN POLYETHYLENE LINERSTRYKER GMBH2020-03-24
UNKNOWN POLYETHYLENE LINERSTRYKER GMBH2020-03-24
UNKNOWN HIP FEMORAL HEADDEPUY INTERNATIONAL LTD - 80103792020-03-24
UNKNOWN KNEE FEMORAL ADAPTOR BOLTDEPUY ORTHOPAEDICS INC US2020-03-24
UNKNOWN POLYETHYLENE LINERSTRYKER GMBH2020-03-24
UNKNOWN POLYETHYLENE LINERSTRYKER GMBH2020-03-24
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-24
UNKNOWN HIP FEMORAL STEMDEPUY ORTHOPAEDICS INC US2020-03-24
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-24
UNKNOWN HIP FEMORAL STEMDEPUY ORTHOPAEDICS INC US2020-03-24
UNKNOWN HIP FEMORAL STEMDEPUY ORTHOPAEDICS INC US2020-03-24
UNKNOWN HIP FEMORAL STEMDEPUY ORTHOPAEDICS INC US2020-03-24
UNKNOWN HIP ACETABULAR LINERSDEPUY ORTHOPAEDICS INC US2020-03-24
UNKNOWN POLYETHYLENE LINERSTRYKER GMBH2020-03-24
UNKNOWN HIP ACETABULAR LINERSDEPUY ORTHOPAEDICS INC US2020-03-23
UNKNOWN HIP FEMORAL HEADDEPUY ORTHOPAEDICS INC US2020-03-23
ELITE MODULAR HD 22.225MM +0DEPUY INTERNATIONAL LTD - 80103792020-03-23
UNKNOWN LINERZIMMER BIOMET, INC.2020-03-23
RLOC-X E1 H/W +3MM 50/36MM 23BIOMET UK LTD.2020-03-23
RINGLOC-X E1 10DEG 52/32MMBIOMET UK LTD.2020-03-22
UNKNOWN HIP FEMORAL STEMDEPUY ORTHOPAEDICS INC US2020-03-20

ยฉ 2022 FDA.report
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