KWZ

Product Code: KWZ


Products Classified as KWZ

4580Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymerHip Joint Metal/polymer Constrained Cemented Or Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4580Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymerHip Joint Metal/polymer Constrained Cemented Or Uncemented Prosthesis.

FDA Consensus Standards

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [34059]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [38231]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [37410]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [37411]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [34710]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [33508]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [32210]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [32380]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [33509]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [33949]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [32381]21 CFR §888.3310 🔎
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer [34694]21 CFR §888.3310 🔎

Pre-market Notifications for KWZ

K163497EXPRTâ„¢ Revision Hip System - EXPRTâ„¢ Hip Distal Stem, EXPRTâ„¢ Hip Standard Offset Proximal Body Implant, EXPRTâ„¢ Hip Lateral Offset Proximal Body Implant, EXPRTâ„¢ Hip Capture BoltENCORE MEDICAL, L.P.
K162641Smith & Nephew, Inc. R3â„¢ Constrained LinerSmith & Nephew, Inc.
K161610EXPRT Revision Hip SystemEncore Medical, L.P.
K122139SMITH & NEPHEW R3 CONSTRAINED LINERSSMITH & NEPHEW, INC.
K111635SMITH & NEPHEW RJ CONSTRAINED LINERSSMITH & NEPHEW, INC.
K101730LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERSZIMMER, INC.
K083566R3 CONSTRAINED LINER, CONSTRAINED LINERSMITH & NEPHEW, INC.
K072121TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINERZIMMER, INC.
K071718TRILOGY LONGEVITY CONSTRAINED LINERZIMMER, INC.
K071676EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGSEXACTECH, INC.
K071117MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERSDEPUY ORTHOPAEDICS, INC.
K071059DEPUY SPA POROUS COATED PROXIMAL SLEEVEDEPUY ORTHOPAEDICS, INC.
K063550SYSTEM 12 CONSTRAINED ACETABULAR LINERSHOWMEDICA OSTEONICS CORP
K063552SERIES II CONSTRAINED ACETABULAR LINERSHOWMEDICA OSTEONICS CORP
K063445PCA CONSTRAINED ACETABULAR LINERSHOWMEDICA OSTEONICS CORP

Global Unique Device Identification Database

00190446324188Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446324171Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446324164Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446164692Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446164678Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446154150Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446154143Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446154105Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446154075Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446154051Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446154020Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446154013Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446153993Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446153962Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
00190446153948Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Maude Adverse Events

DURALOC CONST LINER 54X32DEPUY ORTHOPAEDICS INC US2020-03-31
PINN LNR CON +4 10D 36IDX56ODDEPUY ORTHOPAEDICS INC US2020-03-31
PROSTALAC ACET CUP 42X32DEPUY ORTHOPAEDICS INC US2020-03-30
PROSTALAC HIGH 105MM STEM SZ1DEPUY ORTHOPAEDICS INC US2020-03-30
PINN LNR CON +4 NEUT 28IDX50ODDEPUY ORTHOPAEDICS INC US2020-03-30
UNKNOWN_32 HEADSTRYKER ORTHOPAEDICS-MAHWAH2020-03-25
PIN LNR CONS NEUT +4 36IDX58ODDEPUY ORTHOPAEDICS INC US2020-03-23
FREEDOM CONSTR HD 36MM T1 STDZIMMER BIOMET, INC.2020-03-23
FREEDOM CONSTR. LINER +5 SZ 23ZIMMER BIOMET, INC.2020-03-23
TRIDENT 0 DEG CONSTRAINED INSERT 28GSTRYKER ORTHOPAEDICS-MAHWAH2020-03-20
PINN LNR CON +4 10D 32IDX54ODDEPUY ORTHOPAEDICS INC US2020-03-19
PINN LNR CON +4 10D 32IDX52ODDEPUY ORTHOPAEDICS INC US2020-03-18
TAPERLOC COMPLETE PPS TYPE 1ZIMMER BIOMET, INC.2020-03-17
PROSTALAC ACET CUP 42X32DEPUY ORTHOPAEDICS INC US2020-03-17
PROSTALAC HIGH 105MM STEM SZ1DEPUY ORTHOPAEDICS INC US2020-03-17
PINN LNR CON +4 NEUT 32IDX52ODDEPUY ORTHOPAEDICS INC US2020-03-17
FREEDOM CONSTR. LINER +5 SZ 23ZIMMER BIOMET, INC.2020-03-13
FREEDOM CONSTR HEADZIMMER BIOMET, INC.2020-03-13
TPRLC XR MP FP T1 PPS 5X95MMZIMMER BIOMET, INC.2020-03-13
S-ROM*LINR LSER,0 DEG,32MM CDEPUY ORTHOPAEDICS INC US2020-03-12
TAPERLOC XR FP TYPE1 PPSZIMMER BIOMET, INC.2020-03-09
TAPERLOC XR MP T1 PPSZIMMER BIOMET, INC.2020-03-09
TAPERLOC 133 MP TYPE1 PPS HOZIMMER BIOMET, INC.2020-03-09
TAPERLOC 133 MP TYPE1 PPS HOZIMMER BIOMET, INC.2020-03-09
TAPERLOC XR MP T1 PPSZIMMER BIOMET, INC.2020-03-09
TAPERLOC XR MP FP T1 PPSZIMMER BIOMET, INC.2020-03-09
TPRLC XR FP TYPE1 PPS 5X130MMZIMMER BIOMET, INC.2020-03-09
OSS 4CM DIAPHYSEAL SEGMENTZIMMER BIOMET, INC.2020-03-06
SHELL POROUS WITH CLUSTER HOLES 52 MMZIMMER BIOMET, INC.2020-03-04
PIN LNR CONS NEUT +4 36IDX56ODDEPUY ORTHOPAEDICS INC US2020-03-03
PINN LNR CON +4 10D 36IDX56ODDEPUY ORTHOPAEDICS INC US2020-03-02
MICRO TAPERLOC COMPLETE PPS TYPE 1ZIMMER BIOMET, INC.2020-03-02
TAPERLOC COMPLETE PPS TYPE 1ZIMMER BIOMET, INC.2020-03-02
TAPERLOC COMPLETE PPS TYPE 1ZIMMER BIOMET, INC.2020-03-02
TPRLC 133 MP TYPE1 PPS SO 17.0 1ZIMMER BIOMET, INC.2020-02-27
TPRLC 133 MP TYPE1 PPS SO 16.0 1ZIMMER BIOMET, INC.2020-02-27
TPRLC 133 MP TYPE1 PPS HO 15.0 M T1ZIMMER BIOMET, INC.2020-02-27
TPRLC 133 MP TYPE1 PPS SO 14.0 1ZIMMER BIOMET, INC.2020-02-27
TPRLC 133 MP TYPE1 PPS HO 17.0 M T1ZIMMER BIOMET, INC.2020-02-27
TLOC 133 MP SP T1 PPSHO 6X97.5 1ZIMMER BIOMET, INC.2020-02-27
TPRLC 133 MP TYPE1 PPS HO 17.0 M T1ZIMMER BIOMET, INC.2020-02-27
PINN LNR CON +4 10D 36IDX56ODDEPUY ORTHOPAEDICS INC US2020-02-26
PINN LNR CON +4 10D 28IDX50ODDEPUY ORTHOPAEDICS INC US2020-02-25
TPRLC 133 MP TYPE1 PPS HO 10.0 M T1ZIMMER BIOMET, INC.2020-02-25
TPRLC 133 MP TYPE1 PPS SO 10.0 1ZIMMER BIOMET, INC.2020-02-25
TPRLC 133 MP TYPE1 PPS HO 16.0 M T1ZIMMER BIOMET, INC.2020-02-25
ECHO POR FMRL NC 12X140MMZIMMER BIOMET, INC.2020-02-24
PINN LNR CON +4 NEUT 28IDX48ODDEPUY ORTHOPAEDICS INC US2020-02-24
PINN LNR CON +4 10D 32IDX54ODDEPUY ORTHOPAEDICS INC US2020-02-21
DURALOC CONST LINER 50X28DEPUY ORTHOPAEDICS INC US2020-02-19
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