| Primary Device ID | 00190376508085 |
| NIH Device Record Key | 16e557f1-23ac-421c-ae3a-302833792975 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATEC Light Cable System |
| Version Model Number | 169-510-S |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | |
| 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 | 00190376508085 [Primary] |
| FDG | Retractor, fiberoptic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
[00190376508085]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-12 |
| Device Publish Date | 2024-02-02 |
| 00190376508092 | MIS Illumination System, Sterile |
| 00190376508085 | LIF Illumination System, Sterile |