BI-METRIC X-SERIES HIP SYSTEM X21-182319

GUDID 00880304183131

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis
Primary Device ID00880304183131
NIH Device Record Keyf04cbc7b-b618-419f-948d-8ab2d985958a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBI-METRIC X-SERIES HIP SYSTEM
Version Model NumberX21-182319
Catalog NumberX21-182319
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
GS100880304183131 [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 [BI-METRIC X-SERIES HIP SYSTEM]

00880304183155X21-182321
00880304183148X21-182320
00880304183131X21-182319
00880304183124X21-182318
00880304183117X21-182317
00880304183100X21-182316
00880304183094X21-182315
00880304183087X21-182314
00880304183070X21-182313
00880304183063X21-182312
00880304183056X21-182311
00880304183049X21-182310
00880304183032X21-182309
00880304183025X21-182308
00880304183001X21-180321
00880304182998X21-180320
00880304182981X21-180319
00880304182974X21-180318
00880304182967X21-180317
00880304182950X21-180316
00880304182943X21-180315
00880304182936X21-180314
00880304182929X21-180313
00880304182912X21-180312
00880304182905X21-180311
00880304182899X21-180310
00880304182882X21-180309
00880304182875X21-180308
00880304182868X21-180307
00880304182851X181321
00880304182844X181320
00880304182837X181319
00880304182820X181318
00880304182813X181317
00880304182806X181316
00880304182790X181315
00880304182783X181314
00880304182776X181313
00880304182769X181312
00880304182752X181311
00880304182745X181310
00880304182738X181309
00880304182721X181308
00880304182714X181307
00880304182707X180321
00880304182691X180320
00880304182684X180319
00880304182677X180318
00880304182660X180317
00880304182653X180316

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