OPTIROM KNEE FIXATOR 09680

GUDID 00880304505056

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 00880304505056
• NIH Device Record Key: bde93ad4-35cc-4411-a81b-d83b73def165
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIROM KNEE FIXATOR
• Version Model Number: 09680
• Catalog Number: 09680
• 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: true
• 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	00880304505056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031093

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00880304505056]

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: 2015-10-24

On-Brand Devices [OPTIROM KNEE FIXATOR]

• 00880304505056: 09680
• 00888480113294: 09549
• 00887868084553: 09665