Biomet® Omega 21™ Spinal Fixation System 129130

GUDID 00880304873810

BIOMET SPINE LLC

Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 00880304873810
• NIH Device Record Key: 36427138-4297-4468-86a1-334ee04b615a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomet® Omega 21™ Spinal Fixation System
• Version Model Number: 129130
• Catalog Number: 129130
• Company DUNS: 018577570
• Company Name: BIOMET SPINE 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: true
• 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)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304873810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942028

FDA Product Code

• JDG: Prosthesis, hip, femoral component, cemented, metal

Sterilization

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

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

[00880304873810]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-01
• Device Publish Date: 2020-06-23

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• 03662663055277 - Vital™ Navigation System: 2022-04-01
• 03662663055284 - Vital™ Navigation System: 2022-04-01
• 03662663055291 - Vital™ Navigation System: 2022-04-01
• 03662663055307 - Vital™ Navigation System: 2022-04-01
• 03662663055314 - Vital™ Navigation System: 2022-04-01