| Primary Device ID | 00190376729527 |
| NIH Device Record Key | 44f92b37-b014-47e9-8455-37d9198a3fa4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATEC A.R.M. |
| Version Model Number | ALP2MARMPINS |
| 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 |
| 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 | 00190376729527 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376729527]
Moist Heat or Steam Sterilization
[00190376729527]
Moist Heat or Steam Sterilization
[00190376729527]
Moist Heat or Steam Sterilization
[00190376729527]
Moist Heat or Steam Sterilization
[00190376729527]
Moist Heat or Steam Sterilization
[00190376729527]
Moist Heat or Steam Sterilization
[00190376729527]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-31 |
| Device Publish Date | 2025-12-23 |
| 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 |
| 00190376729534 | Mech A.R.M. 2.0 LTP INS |
| 00190376729527 | Mech A.R.M. 2.0 PTP INS |
| 00190376729473 | MECH ARM 2.0 PTP HANDLE GRIP |
| 00190376678887 | MECH ARM 2.0 LTP HANDLE |
| 00190376678832 | Pneumatic Actuation and Regulation System 2.0 |
| 00190376678825 | MECH ARM 2.0 RELEASE TOOL |
| 00190376678818 | MECH ARM 2.0 SETUP TOOL |
| 00190376678801 | MECH ARM 2.0 LTP T-HANDLE DRIVER |
| 00190376678795 | MECH ARM 2.0 LTP BUTTON HOLDER |
| 00190376678788 | MECH ARM 2.0 LTP STEERING TOOL |
| 00190376678771 | MECH ARM 2.0 LTP DRAPE ADAPTER |
| 00190376678764 | MECH ARM 2.0 PNEUMATIC BUTTON KIT |
| 00190376678757 | MECH ARM 2.0 PTP BUTTON HOLDER |
| 00190376678740 | MECH ARM 2.0 PTP HANDLE |
| 00190376678689 | MECH ARM 2.0 |
| 00190376678672 | MECH ARM 2.0 AIR LINE |
| 00190376678665 | MECH ARM 2.0 CONTROL BOX |