Primary Device ID | 00190376537092 |
NIH Device Record Key | 74469e59-4c0a-4e63-989b-2321b04c69d6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ATEC A.R.M. |
Version Model Number | 102-120 |
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 | 00190376537092 [Primary] |
FQO | Table, operating-room, ac-powered |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
Moist Heat or Steam Sterilization
[00190376537092]
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 |