32-8105-053-01

GUDID 00889024274112

Zimmer, Inc.

Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis

• Primary Device ID: 00889024274112
• NIH Device Record Key: 88809479-9e25-4695-80dc-b77dfdb38af5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 32-8105-53-01
• Catalog Number: 32-8105-053-01
• 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

Device Dimensions

• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024274112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001989

FDA Product Code

• JDC: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

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: 2015-09-17

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