Product Code: OQI


Products Classified as OQI

4667Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous UncementedHip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4667Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous UncementedHip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis.

FDA Consensus Standards

Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34059]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [38231]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34070]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34070]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34070]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34070]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34070]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34070]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34070]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34070]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34070]21 CFR §888.3353 ๐Ÿ”Ž
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented [34070]21 CFR §888.3353 ๐Ÿ”Ž

Pre-market Notifications for OQI

K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.
K173583Exactechยฎ Novationยฎ And AcuMatchยฎ E-HXL Acetabular LinersExactech, Inc.
K172833E-XPE Acetabular Components And U-Motion II Acetabular CupUnited Orthopedic Corporation
K111481CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERSCORIN U.S.A.

Global Unique Device Identification Database

00816127024061Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127023774Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127023750Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127023736Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127023712Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127023699Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127023675Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127022753Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127022739Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127022715Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127022692Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127022678Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127022661Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127022647Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
00816127022623Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Maude Adverse Events

G7 OSSEOTI 4 HOLE SHELL 60MM GZIMMER BIOMET, INC.2020-03-25
G7 OSSEOTI 3 HOLE SHELL 48MM CZIMMER BIOMET, INC.2020-03-06
G7 OSSEOTI MULTIHOLE 52MM EZIMMER BIOMET, INC.2020-02-27
G7 STR INSRTR THREADED SHAFTZIMMER BIOMET, INC.2019-10-09
G7 FREEDOM CONST E1 LNR 36MM GZIMMER BIOMET, INC.2019-06-14
DELTA CER FEM HD 32/-3MM T1BIOMET UK LTD.2019-02-04
DELTA CER FEM HD 32/-3MM T1BIOMET UK LTD.2019-01-15
RENOVISRENOVIS SURGICAL TECHNOLOGIES2018-12-12
NEUTRAL LINER 32 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELLZIMMER BIOMET, INC.2018-10-08
SC/MSC CERAMICS INSERT 32MM 56/58 SYM.AESCULAP IMPLANT SYSTEMS2018-04-25
UNKNOWN BIOLOX HEADZIMMER GMBH2018-03-29
VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE NEUTRAL LINERZIMMER BIOMET, INC.2018-03-23
CONTINUUM TRILOGY ALLOFIT VIVACIT-E ELEVATED RIM LINERZIMMER BIOMET, INC.2017-09-26
ELEVATED RIM LINERZIMMER, INC.2017-08-08
NEUTRAL LINER 36 MMZIMMER, INC.2017-05-05
VIVACIT-E VITAMN E HIGHLY CROSSLINKED POLY LINERZIMMER, INC.2017-01-10
CONTINUUM, TRILOGY IT, ALLOFIT IT LONGEVITY POLY LINERZIMMER MANUFACTURING B.V.2016-12-07
ZIMMER VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINERZIMMER, INC.2016-11-07
ZIMMER VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINERZIMMER, INC.2016-11-07
VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINERZIMMER, INC.2016-10-11
VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINERZIMMER, INC.2016-10-11
CONTINUUM, ALLOFIT IT, TRILOGY IT VIVACIT-E POLY LINERZIMMER, INC.2016-10-06
VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERZIMMER, INC.2016-09-19
ZIMMER VITAMIN-E ELEVATED LINERZIMMER, INC.2016-09-09
TRINITYCORIN MEDICAL2016-08-04
CONTINUUM VIVACIT-E POLYETHYLENE LINERZIMMER, INC.2016-08-02
CONTINUUM TRILOGY IT ALLOFIT VAVACIT-E HIGHLY CROSSLINKED POLY NEUTRAL LINERZIMMER, INC.2016-07-12
VIVACIT-E POLYETHYLENE NEUTRAL LINERZIMMER, INC.2016-06-20
VIVACIT-E CROSSLINKED POLYETHYLENE ELEVATED RIM LINERZIMMER, INC.2016-05-17
CONTINUUM, TRILOGY IT, ALLOFIT IT POLY LINERZIMMER, INC. - BUILDING 52016-04-26
VIVACIT-E HIGHLY CROSSLINKED LINER ELEVATEDZIMMER INC2016-04-08
CONTINUUM TRILOGY VIVACIT-E NEUTRAL LINERZIMMER INC2016-03-23
CONTINUUM VIVACIT-E POLY LINERZIMMER INC2016-03-04
ZIMMER VIVACIT-E ELEVATED LINERZIMMER INC2016-02-16
CONTINUUM VIVACIT-E NEUTRAL POLY LINERZIMMER INC2015-12-21
TRINITY ACETABULAR SYSTEMCORIN MEDICAL2015-08-17
TRINITY ACETABULAR SYSTEMCORIN MEDICAL2015-08-07
EXP ACETABULAR SHELL AND LINERSTELKAST, INC.2015-07-30
TRINITY ACETABULAR SYSTEMCORIN MEDICAL2015-07-28
FEMORAL STEM-STD NECK-SIZE 2 IMPLANTSTRYKER ORTHOPAEDICS-MAHWAH2015-07-07
ACE SHELL-CLUST HOLE POR-58MM IMPLANTSTRYKER ORTHOPAEDICS-MAHWAH2015-06-01
ACE SHELL-CLUST HOLE POR-58MM IMPLANTSTRYKER ORTHOPAEDICS-MAHWAH2015-05-12
FEM STEM-HI OFFSET NK-SIZE 1 IMPLANTSTRYKER ORTHOPAEDICS-MAHWAH2015-03-13
S-ROM HEAD FEMORAL COCR 28+3DEPUY INTERNALTIONAL, LTD.2006-05-15

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