802503606

GUDID 00889024499539

Zimmer, Inc.

Femoral head prosthesis trial
Primary Device ID00889024499539
NIH Device Record Keyacda15e1-9c9e-4e30-b6a8-85d2920fa33d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number802503606
Catalog Number802503606
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 Numberfalse
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

Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024499539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024499539]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-27
Device Publish Date2020-03-19

Devices Manufactured by Zimmer, Inc.

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00889024678743 - OsseoFit™ Stemless Shoulder2024-12-26
00889024678750 - OsseoFit™ Stemless Shoulder2024-12-26
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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