N/A

GUDID 00889024261914

Zimmer, Inc.

Tibial insert
Primary Device ID00889024261914
NIH Device Record Key03674c48-9d5f-48ac-abc2-9249a621408c
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number6811-02-011
Company DUNS056038268
Company NameZimmer, Inc.
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)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

Height11 Millimeter
Device Size Text, specify0
Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter
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Height11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024261914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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 Date2015-09-17

On-Brand Devices [N/A]

0088902419799200-5852-054-19
0088902419798500-5852-054-18
0088902419797800-5852-054-17
0088902419796100-5852-054-16
0088902419795400-5852-054-15
0088902419794700-5852-054-14
0088902419793000-5852-054-13
0088902419792300-5852-054-12
0088902419791600-5852-052-19
0088902419790900-5852-052-18
0088902419789300-5852-052-17
0088902419788600-5852-052-16
0088902419787900-5852-052-15
0088902419786200-5852-052-14
0088902419785500-5852-052-13
0088902419784800-5852-052-12
0088902419780000-5852-050-19
0088902419779400-5852-050-18
0088902419778700-5852-050-17
0088902419777000-5852-050-16
0088902419776300-5852-050-15
0088902419775600-5852-050-14
0088902419774900-5852-050-13
0088902419773200-5852-050-12
0088902419769500-5852-042-17
0088902419768800-5852-042-09
0088902419630800-5850-070-13
0088902419629200-5850-070-12
0088902419628500-5850-060-26
0088902419627800-5850-060-23
0088902419626100-5850-060-20
0088902419625400-5850-060-17
0088902419624700-5850-060-14
0088902419623000-5850-060-12
0088902419622300-5850-050-26
0088902419621600-5850-050-23
0088902419620900-5850-050-20
0088902419619300-5850-050-17
0088902419618600-5850-050-14
0088902419617900-5850-050-12
0088902419616200-5850-048-20
0088902419615500-5850-048-09
0088902419614800-5850-048-08
0088902419612400-5850-046-45
0088902419611700-5850-046-35
0088902419610000-5850-046-22
0088902419609400-5850-046-20
0088902419608700-5850-046-18
0088902419607000-5850-046-16
0088902419606300-5850-046-14

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