M/DN

GUDID 00889024043220

Zimmer, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00889024043220
• NIH Device Record Key: 5a9b3759-0462-4fbf-adec-b8a957b9c935
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M/DN
• Version Model Number: 2253-52-42
• 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@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Length: 52.5 Millimeter
• Length: 52.5 Millimeter
• Device Size Text, specify: 0
• Length: 52.5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024043220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142281

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

Devices Manufactured by Zimmer, Inc.

• 00889024685581 - MODIFIED EXACT OFFSET BROACH HANDLE: 2025-03-11
• 00889024687288 - Reusable 3.2mm Pin - 178mm long: 2025-03-11
• 00889024687431 - SPRING PLUNGER ASSY, STD: 2025-03-11
• 00889024687448 - SPRING PLUNGER ASSY, AGGRESSIVE: 2025-03-11
• 00889024658134 - Persona® Knee System: 2025-02-14
• 00889024658141 - Persona® Knee System: 2025-02-14
• 00889024658158 - Persona® Knee System: 2025-02-14
• 00889024658165 - Persona® Knee System: 2025-02-14