ATEC A.R.M.

GUDID 00190376542928

PTP Mech A-Arm Instruments Alpha

ALPHATEC SPINE, INC.

Instrument tray, reusable

• Primary Device ID: 00190376542928
• NIH Device Record Key: 70619176-066b-4732-98d8-b545abaa209e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATEC A.R.M.
• Version Model Number: ARMINSA
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
• 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	00190376542928 [Primary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

[00190376542928]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-24
• Device Publish Date: 2025-03-14

On-Brand Devices [ATEC A.R.M.]

• 00190376542928: PTP Mech A-Arm Instruments Alpha
• 00190376537092: MECH A-ARM CONTROL BOX
• 00190376532448: MECH A-ARM CONTROL HARNESS
• 00190376532424: MECH A-ARM TARGETING CROSS
• 00190376532417: MECH A-ARM DRAPE CONNECTOR
• 00190376532400: MECH A-ARM
• 00190376532394: Pneumatic Actuation and Regulation System