NexGen® Legacy® Gender Solutions™ 00-5764-016-51

GUDID 00889024192270

Zimmer, Inc.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00889024192270
• NIH Device Record Key: b62a16b8-6e3f-4303-85ba-b4f81f063119
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen® Legacy® Gender Solutions™
• Version Model Number: 00-5764-016-51
• Catalog Number: 00-5764-016-51
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024192270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060370

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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: 6
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-09-24

On-Brand Devices [NexGen® Legacy® Gender Solutions™]

• 00889024192300: 00-5764-017-52
• 00889024192294: 00-5764-017-51
• 00889024192287: 00-5764-016-52
• 00889024192270: 00-5764-016-51
• 00889024192263: 00-5764-015-52
• 00889024192256: 00-5764-015-51
• 00889024192249: 00-5764-014-52
• 00889024192232: 00-5764-014-51
• 00889024192225: 00-5764-013-52
• 00889024192218: 00-5764-013-51