00-2357-005-10

GUDID 00889024055575

Zimmer, Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00889024055575
• NIH Device Record Key: 3e820c7c-02c3-47a8-b940-e84469181987
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2357-05-10
• Catalog Number: 00-2357-005-10
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 189 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024055575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042598

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889024055575]

Moist Heat or Steam Sterilization

[00889024055575]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-10
• Device Publish Date: 2017-09-28

Devices Manufactured by Zimmer, Inc.

• 00889024693012 - Left 3 Deg Tib Cut Guide Assy: 2025-12-26
• 00889024693029 - Right 3 Deg Tib Cut Guide Assy: 2025-12-26
• 00889024703445 - TM Ankle Burr Guard C Large: 2025-12-26
• 00889024703872 - Offset Box Osteotome: 2025-12-26
• 00889024704008 - LB Type 1 Taper Extraction Insert: 2025-12-26
• 00889024704015 - LZ 12/14 Taper Extraction Insert: 2025-12-26
• 00889024704022 - LB 12/14 Taper Extraction Insert: 2025-12-26
• 00889024704039 - Fitmore Extraction Adapter - M: 2025-12-26