00-5850-060-20

GUDID 00889024700598

Zimmer, Inc.

Tibial insert
Primary Device ID00889024700598
NIH Device Record Key71a5c517-2963-4574-97dd-148b353e79bf
Commercial Distribution StatusIn Commercial Distribution
Version Model Number00-5850-060-20
Catalog Number00-5850-060-20
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024700598 [Primary]

FDA Product Code

KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-15
Device Publish Date2025-09-05

Devices Manufactured by Zimmer, Inc.

00889024691315 - Identity Humeral2025-09-30
00889024691353 - Identity Humeral2025-09-30
00889024691476 - Identity Humeral2025-09-30
00889024691551 - Identity Humeral2025-09-30
00889024691582 - Identity Humeral2025-09-30
00889024691681 - Identity Humeral2025-09-30
00889024691728 - Identity Humeral2025-09-30
00889024691919 - Identity Humeral2025-09-30

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