TM Total Ankle 82-0175-162-00

GUDID 00889024471375

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00889024471375
NIH Device Record Key87bbb7af-5448-4962-8f3d-e93c32f7728c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTM Total Ankle
Version Model Number82-0175-162-00
Catalog Number82-0175-162-00
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024471375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


[00889024471375]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-30

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00889024678767 - OsseoFit™ Stemless Shoulder2024-12-26
00889024678774 - OsseoFit™ Stemless Shoulder2024-12-26
00889024678781 - OsseoFit™ Stemless Shoulder2024-12-26
00889024678798 - OsseoFit™ Stemless Shoulder2024-12-26
00889024678804 - OsseoFit™ Stemless Shoulder2024-12-26

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