VEA

GUDID 00190376470351

Vea - Mobile Alignment App

ALPHATEC SPINE, INC.

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.

• 00190376666815 - IdentiTi II: 2025-09-16 ALIF SA SCREW, Ø5.0 x 22.5 mm
• 00190376666822 - IdentiTi II: 2025-09-16 ALIF SA SCREW, Ø5.0 x 27.5 mm
• 00190376666839 - IdentiTi II: 2025-09-16 ALIF SA SCREW, Ø5.0 x 30.0 mm
• 00190376666846 - IdentiTi II: 2025-09-16 ALIF SA SCREW, Ø5.0 x 32.5 mm
• 00190376666853 - IdentiTi II: 2025-09-16 ALIF SA SCREW, Ø5.0 x 35.0 mm
• 00190376666860 - IdentiTi II: 2025-09-16 ALIF SA SCREW, Ø5.0 x 37.5 mm
• 00190376666877 - IdentiTi II: 2025-09-16 ALIF SA SCREW, Ø5.0 x 40.0 mm
• 00190376666884 - IdentiTi II: 2025-09-16 ALIF SA SCREW, Ø5.5 x 22.5 mm