00-5224-033-07

GUDID 00889024188075

Zimmer, Inc.

Tibial insert
Primary Device ID00889024188075
NIH Device Record Key143942c7-0086-437f-8106-34278ccaaa64
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5224-33-07
Catalog Number00-5224-033-07
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@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024188075 [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 Number4
Public Version Date2019-07-31
Device Publish Date2017-10-20

Devices Manufactured by Zimmer, Inc.

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00887868582059 - Affixus®2024-10-25
00887868582066 - Affixus®2024-10-25
00887868582073 - Affixus®2024-10-25
00887868582080 - Affixus®2024-10-25
00887868582097 - Affixus®2024-10-25

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