00-2347-013-08

GUDID 00889024051218

Zimmer, Inc.

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device ID00889024051218
NIH Device Record Key2941375e-b11f-42e9-ae6b-cc348d9e4bb6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2347-13-08
Catalog Number00-2347-013-08
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

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
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

Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024051218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
NDFPLATE, FIXATION, BONE, NON-SPINAL, METALLIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-01-17
Device Publish Date2015-09-24

Devices Manufactured by Zimmer, Inc.

00889024678736 - OsseoFit™ Stemless Shoulder2024-12-26
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

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