00-2358-027-05

GUDID 00889024056985

Zimmer, Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00889024056985
NIH Device Record Key6a3d9f68-fbe2-4f53-93dc-2775b35919f8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2358-27-05
Catalog Number00-2358-027-05
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 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

Device Dimensions

Device Size Text, specify0
Length51 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024056985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024056985]

Moist Heat or Steam Sterilization


[00889024056985]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-14
Device Publish Date2017-09-28

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.