802304002

GUDID 00889024499348

Zimmer, Inc.

Femoral head prosthesis trial
Primary Device ID00889024499348
NIH Device Record Keyafe48d83-22ee-43f6-8a0b-e8767065a0d4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number802304002
Catalog Number802304002
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
GS100889024499348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024499348]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-20
Device Publish Date2019-06-07

Devices Manufactured by Zimmer, Inc.

00889024660595 - BIOMET Anterior Adapter2024-04-23
00889024660601 - BIOMET Posterior Adapter2024-04-23
00889024660816 - +9MM Spacer Block C/D 10mm 2024-04-23
00889024660823 - +9MM Spacer Block C/D 12mm 2024-04-23
00889024660830 - +9MM Spacer Block C/D 14mm 2024-04-23
00889024660847 - +9MM Spacer Block C/D 16mm 2024-04-23
00889024660854 - +9MM Spacer Block C/D 18mm 2024-04-23
00889024660861 - +9MM Spacer Block C/D 20mm 2024-04-23

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