INTEGRAL X-SERIES HIP SYSTEM X12-171316

GUDID 00880304650459

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular
Primary Device ID00880304650459
NIH Device Record Key9b82e036-ff4a-4ffb-8e63-9bee4990c1ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTEGRAL X-SERIES HIP SYSTEM
Version Model NumberX12-171316
Catalog NumberX12-171316
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
GS100880304650459 [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 [INTEGRAL X-SERIES HIP SYSTEM]

00880304650503X12-171321
00880304650497X12-171320
00880304650480X12-171319
00880304650473X12-171318
00880304650466X12-171317
00880304650459X12-171316
00880304650442X12-171315
00880304650435X12-171314
00880304650428X12-171313
00880304650411X12-171312
00880304650404X12-171311
00880304650398X12-171310
00880304650381X12-171309
00880304650374X12-171308
00880304650367X12-171307
00880304182554X170321
00880304182547X170320
00880304182530X170319
00880304182523X170318
00880304182516X170317
00880304182509X170316
00880304182493X170315
00880304182486X170314
00880304182479X170313
00880304182462X170312
00880304182455X170311
00880304182448X170310
00880304182431X170309
00880304182424X170308
00880304182417X170307
00880304182264X11-170321
00880304182257X11-170320
00880304182240X11-170319
00880304182233X11-170318
00880304182226X11-170317
00880304182219X11-170316
00880304182202X11-170315
00880304182196X11-170314
00880304182189X11-170313
00880304182172X11-170312
00880304182165X11-170311
00880304182158X11-170310
00880304182141X11-170309
00880304182134X11-170308

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