Taperloc Complete Hip System SSI003792

GUDID 00880304907416

Biomet Orthopedics, LLC

Orthopaedic broach

• Primary Device ID: 00880304907416
• NIH Device Record Key: c97a7abc-4994-42c3-aa2f-88b6ea126c43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Taperloc Complete Hip System
• Version Model Number: SSI003792
• Catalog Number: SSI003792
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304907416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101086

FDA Product Code

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

Sterilization

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

[00880304907416]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-27

On-Brand Devices [Taperloc Complete Hip System]

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