N/A

GUDID 00889024261990

Zimmer, Inc.

Tibial insert
Primary Device ID00889024261990
NIH Device Record Key5aed2aa4-6dd6-4ae8-ba50-d6730b40be52
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number6811-03-016
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

Device Dimensions

Height16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024261990 [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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