OSS PLATFORM AUGMENT TRIAL 110018747

GUDID 00880304679320

Biomet Orthopedics, LLC

Knee femur prosthesis trial

• Primary Device ID: 00880304679320
• NIH Device Record Key: d4440e0d-4526-46ab-97b5-ddf370600086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS PLATFORM AUGMENT TRIAL
• Version Model Number: 110018747
• Catalog Number: 110018747
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304679320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141331

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

[00880304679320]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-27

Devices Manufactured by Biomet Orthopedics, LLC

• 00887868254451 - Comprehensive® Reverse Shoulder: 2024-11-21
• 00887868578250 - Comprehensive®: 2024-11-13
• 08428898885684 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 08428898885691 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 00880304338548 - AGC ANTERIOR FILE: 2024-09-11
• 00880304339224 - PARALLEL PULLER: 2024-09-11
• 00880304342187 - AGC MODULAR TIBIAL II: 2024-09-11
• 00880304365247 - BIO-MODULAR: 2024-09-11