Persona®

GUDID 00880304809109

Biomet Orthopedics, LLC

Osteotomy guide

• Primary Device ID: 00880304809109
• NIH Device Record Key: 5ad544f8-76b2-4431-ba25-307df2de4029
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Persona®
• Version Model Number: 42-5399-053-85
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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)348-9500
• Email: customerservice@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 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 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	00880304809109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200151

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• HTJ: GAUGE, DEPTH

Sterilization

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

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

[00880304809109]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-13

On-Brand Devices [Persona®]

• 00880304812772: 42-5380-009-02
• 00880304812765: 42-5380-009-01
• 00880304812758: 42-5380-008-02
• 00880304812741: 42-5380-008-01
• 00880304812734: 42-5380-007-02
• 00880304812727: 42-5380-007-01
• 00880304812710: 42-5380-006-02
• 00880304812703: 42-5380-006-01
• 00880304812697: 42-5380-005-02
• 00880304812680: 42-5380-005-01
• 00880304812673: 42-5380-004-02
• 00880304812666: 42-5380-004-01
• 00880304812659: 42-5380-003-02
• 00880304812642: 42-5380-003-01
• 00880304810242: 42-5399-091-00
• 00880304810235: 42-5399-090-00
• 00880304810228: 42-5299-003-00
• 00880304810211: 42-5299-003-01
• 00880304810204: 42-5099-035-14
• 00880304810198: 42-5099-035-12
• 00880304810181: 42-5099-035-10
• 00880304810174: 42-5099-035-09
• 00880304810167: 42-5099-035-08
• 00880304810150: 42-5399-017-10
• 00880304810143: 42-5399-017-03
• 00880304810136: 42-5181-009-14
• 00880304810129: 42-5181-009-12
• 00880304810112: 42-5181-009-11
• 00880304810105: 42-5181-009-10
• 00880304810099: 42-5181-009-09
• 00880304810082: 42-5181-009-08
• 00880304810075: 42-5181-008-14
• 00880304810068: 42-5181-008-12
• 00880304810051: 42-5181-008-11
• 00880304810044: 42-5181-008-10
• 00880304810037: 42-5181-008-09
• 00880304810020: 42-5181-008-08
• 00880304810013: 42-5181-007-14
• 00880304810006: 42-5181-007-12
• 00880304809994: 42-5181-007-11
• 00880304809987: 42-5181-007-10
• 00880304809970: 42-5181-007-09
• 00880304809963: 42-5181-007-08
• 00880304809956: 42-5181-006-14
• 00880304809949: 42-5181-006-12
• 00880304809932: 42-5181-006-11
• 00880304809925: 42-5181-006-10
• 00880304809918: 42-5181-006-09
• 00880304809901: 42-5181-006-08
• 00880304809895: 42-5181-005-14