00-4828-012-02

GUDID 00889024072206

Zimmer, Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00889024072206
• NIH Device Record Key: 8fbe6c8b-67d1-4597-bbbf-e9489c218866
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 00-4828-012-02
• Catalog Number: 00-4828-012-02
• 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
• 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

• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024072206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063303

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00889024072206]

Moist Heat or Steam Sterilization

[00889024072206]

Moist Heat or Steam Sterilization

[00889024072206]

Moist Heat or Steam Sterilization

[00889024072206]

Moist Heat or Steam Sterilization

[00889024072206]

Moist Heat or Steam Sterilization

[00889024072206]

Moist Heat or Steam Sterilization

[00889024072206]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-22
• Device Publish Date: 2016-07-13

Devices Manufactured by Zimmer, Inc.

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• 00887868139635 - Affixus®: 2024-11-18
• 00887868139642 - Affixus®: 2024-11-18
• 00887868139659 - Affixus®: 2024-11-18
• 00887868139666 - Affixus®: 2024-11-18
• 00887868139673 - Affixus®: 2024-11-18
• 00887868139680 - Affixus®: 2024-11-18