OSS EXPANDABLE TRIAL BUTTON ASSEMBLY 110018632

GUDID 00880304678217

Biomet Orthopedics, LLC

Knee femur prosthesis trial

• Primary Device ID: 00880304678217
• NIH Device Record Key: f3d6d644-335d-455c-b095-ec080937fb73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS EXPANDABLE TRIAL BUTTON ASSEMBLY
• Version Model Number: 110018632
• Catalog Number: 110018632
• 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	00880304678217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141331

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

Moist Heat or Steam Sterilization

[00880304678217]

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

• 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
• 00880304368637 - BOHN MODULAR FEMORAL STEM EXTRACTOR: 2024-09-11
• 00880304368682 - BOHN MODULAR FEMORAL STEM EXTRACTOR: 2024-09-11