SIRIUS HIP SYSTEM 51-199352

GUDID 00880304542822

Biomet Orthopedics, LLC

Uncoated knee femur prosthesis, metallic
Primary Device ID00880304542822
NIH Device Record Key678e0a45-536d-48ac-bca4-f72a5760f968
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIRIUS HIP SYSTEM
Version Model Number51-199352
Catalog Number51-199352
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
GS100880304542822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQIHip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-10-24

On-Brand Devices [SIRIUS HIP SYSTEM]

0088030465212551-199331
00880304543683596046
00880304543676596044
00880304543669596045
0088030454283951-199342
0088030454282251-199352
0088030454281551-199332
0088030454280851-199351
0088030454279251-199335
0088030454278551-199343
0088030454277851-199333
0088030454276151-199341
0088030454275451-199336
0088030454274751-199337
0088030454272351-199301
0088030454271651-199300
0088030454264851-199334

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