Trabecular Metal™ Prolong® 00-4500-056-00

GUDID 00889024269842

Zimmer, Inc.

Fixed-bearing total ankle prosthesis

• Primary Device ID: 00889024269842
• NIH Device Record Key: 3e25dede-5c25-49d8-81ba-457a08df34be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trabecular Metal™ Prolong®
• Version Model Number: 00-4500-056-00
• Catalog Number: 00-4500-056-00
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024269842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120906

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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: 2019-10-09
• Device Publish Date: 2015-09-17

On-Brand Devices [Trabecular Metal™ Prolong®]

• 00889024269866: 00-4500-056-04
• 00889024269859: 00-4500-056-02
• 00889024269842: 00-4500-056-00
• 00889024269835: 00-4500-055-04
• 00889024269828: 00-4500-055-02
• 00889024269811: 00-4500-055-00
• 00889024269804: 00-4500-054-04
• 00889024269798: 00-4500-054-02
• 00889024269781: 00-4500-054-00
• 00889024269774: 00-4500-053-04
• 00889024269767: 00-4500-053-02
• 00889024269750: 00-4500-053-00
• 00889024269743: 00-4500-052-04
• 00889024269736: 00-4500-052-02
• 00889024269729: 00-4500-052-00
• 00889024269712: 00-4500-051-04
• 00889024269705: 00-4500-051-02
• 00889024269699: 00-4500-051-00