Persona® Knee System 42-5399-061-02

GUDID 00889024630536

Zimmer, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00889024630536
• NIH Device Record Key: 4186f21c-a6f8-48dc-8321-7d9d4bcee2a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Persona® Knee System
• Version Model Number: 42-5399-061-02
• Catalog Number: 42-5399-061-02
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00889024630536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113369

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00889024630536]

Moist Heat or Steam Sterilization

[00889024630536]

Moist Heat or Steam Sterilization

[00889024630536]

Moist Heat or Steam Sterilization

[00889024630536]

Moist Heat or Steam Sterilization

[00889024630536]

Moist Heat or Steam Sterilization

[00889024630536]

Moist Heat or Steam Sterilization

[00889024630536]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-13
• Device Publish Date: 2024-11-05

On-Brand Devices [Persona® Knee System]

• 00889024656369: 42-5399-023-00
• 00889024656352: 42-5399-002-00
• 00889024656345: 42-5399-001-00
• 00889024656338: 42-5299-001-00
• 00889024656314: 42-5099-014-00
• 00889024656307: 42-5097-012-00
• 00889024656291: 42-5097-011-00
• 00889024656284: 42-5041-052-02
• 00889024656277: 42-5041-052-01
• 00889024656260: 42-5041-050-02
• 00889024656253: 42-5041-050-01
• 00889024656246: 42-5021-052-02
• 00889024656239: 42-5021-052-01
• 00889024656222: 42-5021-050-02
• 00889024656215: 42-5021-050-01
• 00889024650497: 42-5099-085-74
• 00889024650480: 42-5099-085-70
• 00889024650473: 42-5099-085-68
• 00889024650466: 42-5099-085-66
• 00889024650459: 42-5099-085-64
• 00889024650442: 42-5099-085-62
• 00889024650435: 42-5099-085-60
• 00889024650428: 42-5099-085-58
• 00889024650411: 42-5099-085-56
• 00889024650404: 42-5099-085-54
• 00889024650381: 42-5099-044-74
• 00889024650374: 42-5099-044-70
• 00889024650367: 42-5099-044-68
• 00889024650350: 42-5099-044-66
• 00889024650343: 42-5099-044-64
• 00889024650336: 42-5099-044-62
• 00889024650329: 42-5099-044-60
• 00889024650312: 42-5099-044-58
• 00889024650305: 42-5099-044-56
• 00889024650299: 42-5099-044-54
• 00889024647961: 42-5099-085-52
• 00889024647954: 42-5099-085-50
• 00889024630604: 42-5399-075-01
• 00889024630536: 42-5399-061-02
• 00889024630529: 42-5399-061-01
• 00889024630499: 42-5376-001-01
• 00889024630482: 42-5376-001-00
• 00889024630475: 42-5279-006-04
• 00889024630468: 42-5279-006-02
• 00889024630451: 42-5279-006-00
• 00889024630444: 42-5279-004-04
• 00889024630437: 42-5279-004-02
• 00889024630420: 42-5279-004-00
• 00889024630413: 42-5279-002-04
• 00889024630406: 42-5279-002-02