MALLORY/HEAD CALCAR HIP SYSTEM 11-104935

GUDID 00880304200098

Biomet Orthopedics, LLC

Coated femoral stem prosthesis, modular
Primary Device ID00880304200098
NIH Device Record Keyd0e026d9-dcaf-4ac2-bbba-e00741769e57
Commercial Distribution StatusIn Commercial Distribution
Brand NameMALLORY/HEAD CALCAR HIP SYSTEM
Version Model Number11-104935
Catalog Number11-104935
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
GS100880304200098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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 [MALLORY/HEAD CALCAR HIP SYSTEM]

0088030428206321-108279
0088030428205621-108277
0088030428204921-108275
0088030428203221-108273
0088030428202521-108271
0088030428201821-108259
0088030428200121-108257
0088030428199821-108255
0088030428198121-108253
0088030428197421-108251
0088030428196721-108159
0088030428195021-108157
0088030428194321-108155
0088030428193621-108152
0088030428192921-108150
0088030428191221-108139
0088030428190521-108137
0088030428189921-108135
0088030428188221-108132
0088030428187521-108130
0088030428186821-108119
0088030428185121-108117
0088030428184421-108115
0088030428183721-108112
0088030428182021-108110
0088030422709513-104915
0088030422708813-104914
0088030422707113-104913
0088030422706413-104912
0088030422705713-104911
0088030420537611-135170
0088030420536911-135169
0088030420535211-135168
0088030420534511-135167
0088030420533811-135165
0088030420532111-135163
0088030420530711-135161
0088030420529111-135160
0088030420410211-108756
0088030420409611-108755
0088030420408911-108753
0088030420407211-108752
0088030420406511-108746
0088030420405811-108745
0088030420404111-108742
0088030420402711-108740
0088030420401011-108459
0088030420400311-108457
0088030420398311-108455
0088030420396911-108451

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