TAPERLOC COMPLETE NECK TRUNNION 51-201000

GUDID 00880304481022

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00880304481022
• NIH Device Record Key: 05e6668f-721b-47b9-90fa-bf6a5061e55a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TAPERLOC COMPLETE NECK TRUNNION
• Version Model Number: 51-201000
• Catalog Number: 51-201000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304481022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101086

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[00880304481022]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-30
• Device Publish Date: 2017-07-28

On-Brand Devices [TAPERLOC COMPLETE NECK TRUNNION]

• 00880304543393: 51-202000
• 00880304507456: 51-201001
• 00880304507449: 51-200001
• 00880304481022: 51-201000