VEA

GUDID 00190376470351

Vea - Mobile Alignment App

ALPHATEC SPINE, INC.

Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software

• Primary Device ID: 00190376470351
• NIH Device Record Key: 7f7fd0ca-db18-4ddc-a1ad-e982a1e53e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VEA
• Version Model Number: AIX21000
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• 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: false
• Serial Number: true
• 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(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	00190376470351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211987

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-07
• Device Publish Date: 2022-06-29

Devices Manufactured by ALPHATEC SPINE, INC.

• 00190376528670 - ATEC Posterior Navigation Disc Prep Instruments: 2024-04-29 POST NAV PS Trial 7 x 9 x 22mm, 0°
• 00190376528687 - ATEC Posterior Navigation Disc Prep Instruments: 2024-04-29 POST NAV PS Trial 7 x 9 x 22mm, 5°
• 00190376528694 - ATEC Posterior Navigation Disc Prep Instruments: 2024-04-29 POST NAV PS Trial 7 x 9 x 22mm, 10°
• 00190376528700 - ATEC Posterior Navigation Disc Prep Instruments: 2024-04-29 POST NAV PS Trial 7 x 9 x 22mm, 15°
• 00190376528717 - ATEC Posterior Navigation Disc Prep Instruments: 2024-04-29 POST NAV PS Trial 8 x 9 x 22mm, 0°
• 00190376528724 - ATEC Posterior Navigation Disc Prep Instruments: 2024-04-29 POST NAV PS Trial 8 x 9 x 22mm, 5°
• 00190376528731 - ATEC Posterior Navigation Disc Prep Instruments: 2024-04-29 POST NAV PS Trial 8 x 9 x 22mm, 10°
• 00190376528748 - ATEC Posterior Navigation Disc Prep Instruments: 2024-04-29 POST NAV PS Trial 8 x 9 x 22mm, 15°