47-4828-048-02

GUDID 00889024100848

Zimmer, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00889024100848
• NIH Device Record Key: 1cbf27b2-3cc4-4410-841e-bcb88e1e78fa
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 47-4828-048-02
• Catalog Number: 47-4828-048-02
• 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: 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

Device Dimensions

• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024100848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063303

FDA Product Code

• HWC: Screw, fixation, bone

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: 2020-01-14
• Device Publish Date: 2015-09-24

Devices Manufactured by Zimmer, Inc.

• 00889024660595 - BIOMET Anterior Adapter: 2024-04-23
• 00889024660601 - BIOMET Posterior Adapter: 2024-04-23
• 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