FINN KNEE SYSTEM 153920

GUDID 00880304006362

Biomet Orthopedics, LLC

Knee arthroplasty wedge
Primary Device ID00880304006362
NIH Device Record Key5375a7cd-54c2-43fb-9682-a4f417346d3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFINN KNEE SYSTEM
Version Model Number153920
Catalog Number153920
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
GS100880304006362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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

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00880304554610153809
00880304554603153808
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00880304268937180048
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00880304268913180046
00880304268906180045
00880304268890180044
00880304268883180043
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00880304268852180040
00880304268845180039
00880304268838180038
00880304268821180037
00880304268807180033
00880304268791180031
00880304268784180030
00880304268777180029
00880304268753180025
00880304244924154093
00880304244900154091
00880304244894154090
00880304244870154087
00880304244863154086
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00880304244702154062
00880304244689154060
00880304244672154056
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00880304244634154053
00880304244627154052
00880304244580154046
00880304244573154044
00880304244542154042
00880304244528154040

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