802303200

GUDID 00889024499201

Zimmer, Inc.

Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial
Primary Device ID00889024499201
NIH Device Record Key971a997a-fba7-4472-8df7-3bdc3bd1aad4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number802303200
Catalog Number802303200
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 Batchtrue
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
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024499201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


[00889024499201]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-28
Device Publish Date2020-08-20

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.