HEXLOC MODULAR HIP SYSTEM 12-104353

GUDID 00880304220188

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner
Primary Device ID00880304220188
NIH Device Record Key5f49a6b1-49ab-471b-b6a1-e7b0a7c080ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEXLOC MODULAR HIP SYSTEM
Version Model Number12-104353
Catalog Number12-104353
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
GS100880304220188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [HEXLOC MODULAR HIP SYSTEM]

0088030422019512-104354
0088030422018812-104353
0088030422017112-104352
0088030422016412-104349
0088030422015712-104348
0088030422014012-104345
0088030422009612-104318
0088030422008912-104317
0088030422007212-104316
0088030422005812-104310
0088030422004112-104309
0088030422003412-104308
0088030422002712-104305
0088030422001012-104303
0088030422000312-104301
0088030401114412-104347
0088030400754312-104346
0088030400215912-104304
0088030400068112-104302

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