Product Code: MEH


Products Classified as MEH

4621Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium PhosphateHip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4621Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium PhosphateHip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis.

FDA Consensus Standards

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [34059]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [38231]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [34070]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [37410]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [37411]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [35610]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [33508]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [32210]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [38290]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [32380]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [33509]21 CFR §888.3353 ๐Ÿ”Ž
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate [33949]21 CFR §888.3353 ๐Ÿ”Ž

Pre-market Notifications for MEH

K210581Actis DuoFix Hip Prosthesis- CollarlessDePuy Ireland UC
K201278World Hip Stem, World Cup, World LinerSignature Orthopaedics Pty Ltd.
K200045MUTARS Cemented Femoral StemsImplantcast, GmbH
K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.
K192883Spartan Hip StemSignature Orthopaedics Pty Ltd.
K181778MUTARS Proximal Femur Replacement SystemImplantcast GmbH
K173880Corin TriFit CF Hip StemCorin USA Limited
K171273LINKยฎ BiMobile(TM) Dual Mobility SystemWaldemar Link Gmbh & Co. KG
K171249Entradaโ„ข Hip StemOrtho Development Corporation
K162732Exactechยฎ Alteonยฎ HA Femoral StemEXACTECH INC
K162303REDAPT Sleeved Monolithic Revision StemsSMITH & NEPHEW INC.
K161155Origin Coxa Vara Hip StemSIGNATURE ORTHOPAEDICS PTY LTD.
K160907DePuy Actis DuoFix Hip ProsthesisDEPUY (IRELAND)
K160011H-Max S StemLIMACORPORATE S.P.A.
K153772Corin TriFit TS HipCORIN USA LIMITED

Global Unique Device Identification Database

00822409036325Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409036288Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409036110Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409036080Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409036059Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409035984Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409035977Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409035939Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409035922Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409035915Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409035908Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409035885Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00822409035823Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00885556715291Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
00885556584521Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Maude Adverse Events

RESTORATION ADM X3 INS 28/52STRYKER ORTHOPAEDICS-MAHWAH2020-03-31
SYN HA PF FEM COMP SZ 15SMITH & NEPHEW, INC.2020-03-31
MODULAR FEMORAL STEM CALCICOAT CERAMIC COATING SIZE 9ZIMMER BIOMET, INC.2020-03-25
FEMORAL HEAD/NECK IMPACTORSMITH & NEPHEW, INC.2020-03-24
TRIAL REMOVAL HANDLESMITH & NEPHEW, INC.2020-03-24
VERSAFITCUP DM DOUBLE MOBILITY HC LINER ? 54/28MEDACTA INTERNATIONAL SA2020-03-24
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMHMEDACTA INTERNATIONAL SA2020-03-24
METHA SHORT HIP STEM ?CAP SIZE 2AESCULAP AG2020-03-18
METHA SHORT HIP STEM ?CAP SIZE 2AESCULAP AG2020-03-18
TRINITY DUAL MOBILITYCORIN MEDICAL2020-03-17
TRINITYCORIN MEDICAL2020-03-16
RESTORATION ADM X3 INS 28/48STRYKER ORTHOPAEDICS-MAHWAH2020-03-13
CUP: VERSAFITCUP ACETABULAR SHELL CC ? 48MEDACTA INTERNATIONAL SA2020-03-13
RESTORATION ADM X3 INS 28/48STRYKER ORTHOPAEDICS-MAHWAH2020-03-07
TRINITYCORIN MEDICAL2020-03-06
SHELL POROUS WITH HOLES 54 MM O.D.ZIMMER BIOMET, INC.2020-02-28
RESTORATION ADM X3 INS 28/48STRYKER ORTHOPAEDICS-MAHWAH2020-02-27
REJUVENATE SPT MODULAR STEMSTRYKER CORP.2020-02-26
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER ? 58/28MEDACTA INTERNATIONAL SA2020-02-26
CUP: VERSAFITCUP ACETABULAR SHELL ? 52MEDACTA INTERNATIONAL SA2020-02-24
LEFT ANTEVERTED MODULAR NECKSMITH & NEPHEW, INC.2020-02-21
RESTORATION ADM X3 INS 28/48STRYKER ORTHOPAEDICS-MAHWAH2020-02-21
ANTHOLOGY INSERTER POSTER HARDSMITH & NEPHEW, INC.2020-02-21
TRINITYCORIN MEDICAL2020-02-21
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER ? 58/28MEDACTA INTERNATIONAL SA2020-02-21
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER ? 52/28MEDACTA INTERNATIONAL SA2020-02-20
LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER ? 56/28MEDACTA INTERNATIONAL SA2020-02-14
ECHELON HA STD 260 BOW S 12 LSMITH & NEPHEW, INC.2020-02-13
UNK VERSA FXZIMMER BIOMET, INC.2020-02-06
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMIMEDACTA INTERNATIONAL SA2020-02-06
UNKNOWN POLYETHYLENE DUAL MOBILITY LINERSTRYKER GMBH2020-02-05
MOD PF REVISION STEM 240MM SZ 13SMITH & NEPHEW, INC.2020-02-05
UNKNOWN POLYETHYLENE DUAL MOBILITY LINERSTRYKER GMBH2020-02-04
EMP 13 STEM PRIMARY SOSMITH & NEPHEW, INC.2020-01-27
FEMORAL STEM 12/14 NECK TAPERZIMMER BIOMET, INC.2020-01-23
REAMER QUICK CONNECTSMITH & NEPHEW, INC.2020-01-21
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER ? 50/28MEDACTA INTERNATIONAL SA2020-01-20
IMPL HIP FEM STEM ECHELON 30X260MM SZ 12SMITH AND NEPHEW, INC.2020-01-16
SCREW REFLECTION SPHERICAL HEAD 15MMSMITH AND NEPHEW, INC.2020-01-16
RESTORATION ADM X3 INS 28/52STRYKER ORTHOPAEDICS-MAHWAH2020-01-16
LINER: MPACT DOUBLE MOBILITY HC LINER ? 54/28MEDACTA INTERNATIONAL SA2020-01-13
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMHMEDACTA INTERNATIONAL SA2020-01-13
FEMORAL HEAD/NECK IMPACTORSMITH & NEPHEW, INC.2020-01-10
TRINITYCORIN MEDICAL2020-01-07
RESTORATION ADM X3 INS 28/48STRYKER ORTHOPAEDICS-MAHWAH2020-01-03
REF SPHER HEAD SCREW 25MMSMITH & NEPHEW, INC.2019-12-24
FEMORAL HEAD/NECK IMPACTORSMITH & NEPHEW, INC.2019-12-23
TRINITYCORIN MEDICAL2019-12-17
TRINITYCORIN MEDICAL2019-12-17
TRINITY DUAL MOBILITYCORIN MEDICAL2019-11-28

ยฉ 2021 FDA.report
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