32-8105-029-00

GUDID 00889024639775

Zimmer, Inc.

Hinged total elbow prosthesis

• Primary Device ID: 00889024639775
• NIH Device Record Key: 1a9abfaf-c9b0-457b-baf2-c454ecfffd69
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 32-8105-29
• Catalog Number: 32-8105-029-00
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024639775 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-07
• Device Publish Date: 2022-02-25

Devices Manufactured by Zimmer, Inc.

• 00889024693012 - Left 3 Deg Tib Cut Guide Assy: 2025-12-26
• 00889024693029 - Right 3 Deg Tib Cut Guide Assy: 2025-12-26
• 00889024703445 - TM Ankle Burr Guard C Large: 2025-12-26
• 00889024703872 - Offset Box Osteotome: 2025-12-26
• 00889024704008 - LB Type 1 Taper Extraction Insert: 2025-12-26
• 00889024704015 - LZ 12/14 Taper Extraction Insert: 2025-12-26
• 00889024704022 - LB 12/14 Taper Extraction Insert: 2025-12-26
• 00889024704039 - Fitmore Extraction Adapter - M: 2025-12-26