PERSONA™ Natural Tibia™ Trabecular Metal™

GUDID 00889024246560

Zimmer, Inc.

Coated knee tibia prosthesis

• Primary Device ID: 00889024246560
• NIH Device Record Key: aa211a2c-2404-456e-8758-ad3302f0c77f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERSONA™ Natural Tibia™ Trabecular Metal™
• Version Model Number: 42-5300-079-02
• 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@zimmer.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024246560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121771

FDA Product Code

• OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-15
• Device Publish Date: 2015-09-17

On-Brand Devices [PERSONA™ Natural Tibia™ Trabecular Metal™]

• 00889024246607: 42-5300-088-02
• 00889024246591: 42-5300-088-01
• 00889024246584: 42-5300-083-02
• 00889024246577: 42-5300-083-01
• 00889024246560: 42-5300-079-02
• 00889024246553: 42-5300-079-01
• 00889024246546: 42-5300-075-02
• 00889024246539: 42-5300-075-01
• 00889024246522: 42-5300-071-02
• 00889024246515: 42-5300-071-01
• 00889024246508: 42-5300-067-02
• 00889024246492: 42-5300-067-01
• 00889024246485: 42-5300-064-02
• 00889024246478: 42-5300-064-01
• 00889024246461: 42-5300-061-02
• 00889024246454: 42-5300-061-01
• 00889024246447: 42-5300-058-02
• 00889024246430: 42-5300-058-01