Arcus

GUDID 00190376240275

Arcus Guided Access System - Bevel Tip, Sterile

ALPHATEC SPINE, INC.

Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system Neurophysiologic monitoring system

• Primary Device ID: 00190376240275
• NIH Device Record Key: 7a51c06d-cf21-41af-99f1-986fe1c7b3c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arcus
• Version Model Number: 16122-02-S
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376240275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191723

FDA Product Code

• PDQ: Neurosurgical nerve locator

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: 2021-03-03
• Device Publish Date: 2021-02-23

On-Brand Devices [Arcus]

• 00190376215884: Arcus Stimulating Targeting Needle, Bevel Tip
• 00190376215877: Arcus Stimulating Targeting Needle, Diamond Tip
• 00190376240275: Arcus Guided Access System - Bevel Tip, Sterile
• 00190376240268: Arcus Guided Access System - Diamond Tip, Sterile
• 00190376309484: Arcus Home-Base Clip