| Primary Device ID | 00190376532424 | 
| NIH Device Record Key | ae8793ac-fd8f-460a-84a4-fe6061a1adf5 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | ATEC A.R.M. | 
| Version Model Number | 102-110-02 | 
| 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 | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| 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 | 
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 | 
| Regulatory@alphatecspine.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00190376532424 [Primary] | 
| FWW | Table, operating-room, pneumatic | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
[00190376532424]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-03-24 | 
| Device Publish Date | 2025-03-14 | 
| 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 |