Taperloc Complete Hip System SSI003743

GUDID 00880304856837

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00880304856837
• NIH Device Record Key: 368bfca1-7e0a-4d48-93ad-c000a0aa8f35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Taperloc Complete Hip System
• Version Model Number: SSI003743
• Catalog Number: SSI003743
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304856837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120030

FDA Product Code

• OQG: Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Sterilization

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

[00880304856837]

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: 2016-12-22

On-Brand Devices [Taperloc Complete Hip System]

• 00880304989191: SSI003777
• 00880304989184: SSI003776
• 00880304907416: SSI003792
• 00880304865792: SSI003774
• 00880304865785: SSI003773
• 00880304856837: SSI003743
• 00880304506992: 595540