TAPERLOC HIP SYSTEM 11-103207

GUDID 00880304009165

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular
Primary Device ID00880304009165
NIH Device Record Key36bc2164-b7bd-4690-9eae-601537a557b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTAPERLOC HIP SYSTEM
Version Model Number11-103207
Catalog Number11-103207
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304009165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-15
Device Publish Date2015-10-24

On-Brand Devices [TAPERLOC HIP SYSTEM]

0088030459166013-103215
0088030459151612-103215
0088030459103511-103216
0088030459102811-103215
00880304553927103216
00880304553910103215
0088030451183521-103215
0088030428228521-123212
0088030428227821-123211
0088030428226121-123210
0088030428225421-123209
0088030428224721-123208
0088030428223021-123207
0088030428222321-123206
0088030428221621-123205
0088030428220921-123204
0088030428219321-123203
0088030428218621-123202
0088030428170721-103212
0088030428169121-103211
0088030428168421-103210
0088030428167721-103209
0088030428165321-103208
0088030428164621-103207
0088030428163921-103206
0088030428162221-103205
0088030428161521-103204
0088030428160821-103203
0088030428159221-103202
0088030422637113-103212
0088030422636413-103211
0088030422635713-103210
0088030422634013-103209
0088030422633313-103208
0088030422632613-103207
0088030422631913-103206
0088030421951912-103212
0088030421950212-103211
0088030421949612-103210
0088030421948912-103209
0088030421947212-103208
0088030421946512-103207
0088030421945812-103206
0088030419829611-103212
0088030419828911-103211
0088030419827211-103210
0088030419826511-103209
0088030419825811-103208
0088030419823411-103206
0088030419822711-103204

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