00-2348-002-12

GUDID 00889024053960

Zimmer, Inc.

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 00889024053960
• NIH Device Record Key: bb7b0a2d-8129-4240-b12b-2c63738cfab5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2348-02-12
• Catalog Number: 00-2348-002-12
• 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: true
• 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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter
• Device Size Text, specify: 0
• Length: 188 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024053960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150121

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented
• NDF: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-10
• Device Publish Date: 2017-10-02

Devices Manufactured by Zimmer, Inc.

• 00889024691315 - Identity Humeral: 2025-09-30
• 00889024691353 - Identity Humeral: 2025-09-30
• 00889024691476 - Identity Humeral: 2025-09-30
• 00889024691551 - Identity Humeral: 2025-09-30
• 00889024691582 - Identity Humeral: 2025-09-30
• 00889024691681 - Identity Humeral: 2025-09-30
• 00889024691728 - Identity Humeral: 2025-09-30
• 00889024691919 - Identity Humeral: 2025-09-30