Advantage C Cervical Interbody Fusion Device 0-

GUDID G079100140712S1

Intelivation, LLC

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• Primary Device ID: G079100140712S1
• NIH Device Record Key: bf5b7e41-79b7-4ac0-a7db-ddf813491452
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage C Cervical Interbody Fusion Device 0-
• Version Model Number: 1001.40712S
• Company DUNS: 037368183
• Company Name: Intelivation, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G079100140712S1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211501

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-25
• Device Publish Date: 2022-04-15

Devices Manufactured by Intelivation, LLC

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• G079HMR0406D0 - Hammerdesis™ Interphalangeal Fusion System: 2024-04-09 Recovery Dowel, Small
• G079HMR102S0 - Hammerdesis™ Interphalangeal Fusion System: 2024-04-09 Inserter, Forceps
• G079HMR1080406H0 - Hammerdesis™ Interphalangeal Fusion System: 2024-04-09 Hole Reamer, Small
• G079HMR1080406P0 - Hammerdesis™ Interphalangeal Fusion System: 2024-04-09 Peg Reamer, Small
• G079HMR1084565H0 - Hammerdesis™ Interphalangeal Fusion System: 2024-04-09 Hole Reamer, Large
• G079HMR1084565P0 - Hammerdesis™ Interphalangeal Fusion System: 2024-04-09 Peg Reamer, Large
• G079HMR116010 - Hammerdesis™ Interphalangeal Fusion System: 2024-04-09 1.1mm K-Wire