SIGNATURE 42-100101

GUDID 00880304516298

Biomet Orthopedics, LLC

Orthopaedic fixation implant alignment tool

• Primary Device ID: 00880304516298
• NIH Device Record Key: 72f1f149-40d0-4044-b116-863976b2a4ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNATURE
• Version Model Number: 42-100101
• Catalog Number: 42-100101
• 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	00880304516298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111863

FDA Product Code

• MAY: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

Sterilization

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

[00880304516298]

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: 2016-09-22

On-Brand Devices [SIGNATURE]

• 00880304928510: 42-422505
• 00880304927490: 42-422411
• 00880304520905: 592815
• 00880304516373: 42-100103
• 00880304516328: 42-100104
• 00880304516304: 42-100102
• 00880304516298: 42-100101
• 00880304507104: 42-422400
• 00880304460225: 42-422401
• 00887868273407: SSI004923