| Primary Device ID | 00190376662282 |
| NIH Device Record Key | 0878a05d-11b8-488e-a987-be8928b86388 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IdentiTi II |
| Version Model Number | 834-5100-3-35 |
| 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 |
| Angle | 35 degree |
| Angle | 35 degree |
| Angle | 35 degree |
| Angle | 35 degree |
| Angle | 35 degree |
| Angle | 35 degree |
| Angle | 35 degree |
| Angle | 35 degree |
| Angle | 35 degree |
| Angle | 35 degree |
| Angle | 35 degree |
| Angle | 35 degree |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376662282 [Primary] |
| HWR | DRIVER, PROSTHESIS |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
[00190376662282]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-15 |
| Device Publish Date | 2025-09-05 |
| 00190376643816 | IdentiTi II PC Instruments Alpha |
| 00190376643762 | IdentiTi II PC 9 x 10 x 40mm, 5° |
| 00190376643755 | IdentiTi II PC 8 x 10 x 40mm, 5° |
| 00190376643748 | IdentiTi II PC 7 x 10 x 40mm, 5° |
| 00190376616162 | IdentiTi II PC 12 x 10 x 30mm, 10° |
| 00190376616155 | IdentiTi II PC 12 x 10 x 30mm, 5° |
| 00190376616148 | IdentiTi II PC 11 x 10 x 35mm, 15° |
| 00190376616131 | IdentiTi II PC 11 x 10 x 35mm, 10° |
| 00190376616124 | IdentiTi II PC 11 x 10 x 30mm, 10° |
| 00190376616117 | IdentiTi II PC 11 x 10 x 30mm, 5° |
| 00190376616100 | IdentiTi II PC 11 x 10 x 25mm, 5° |
| 00190376616094 | IdentiTi II PC 10 x 10 x 35mm, 15° |
| 00190376616087 | IdentiTi II PC 10 x 10 x 35mm, 10° |
| 00190376616070 | IdentiTi II PC 10 x 10 x 30mm, 10° |
| 00190376616063 | IdentiTi II PC 10 x 10 x 30mm, 5° |
| 00190376616056 | IdentiTi II PC 10 x 10 x 25mm, 5° |
| 00190376616049 | IdentiTi II PC 9 x 10 x 35mm, 15° |
| 00190376616032 | IdentiTi II PC 9 x 10 x 35mm, 10° |
| 00190376616025 | IdentiTi II PC 9 x 10 x 30mm, 15° |
| 00190376616018 | IdentiTi II PC 9 x 10 x 30mm, 10° |
| 00190376616001 | IdentiTi II PC 9 x 10 x 30mm, 5° |
| 00190376615998 | IdentiTi II PC 9 x 10 x 25mm, 5° |
| 00190376615981 | IdentiTi II PC 8 x 12 x 35mm, 15° |
| 00190376615974 | IdentiTi II PC 8 x 12 x 30mm, 10° |
| 00190376615967 | IdentiTi II PC 8 x 10 x 35mm, 15° |
| 00190376615950 | IdentiTi II PC 8 x 10 x 35mm, 10° |
| 00190376615943 | IdentiTi II PC 8 x 10 x 30mm, 15° |
| 00190376615936 | IdentiTi II PC 8 x 10 x 30mm, 10° |
| 00190376615929 | IdentiTi II PC 8 x 10 x 30mm, 5° |
| 00190376615912 | IdentiTi II PC 8 x 10 x 25mm, 5° |
| 00190376615905 | IdentiTi II PC 7 x 12 x 35mm, 15° |
| 00190376615899 | IdentiTi II PC 7 x 12 x 30mm, 10° |
| 00190376615882 | IdentiTi II PC 7 x 10 x 35mm, 15° |
| 00190376615875 | IdentiTi II PC 7 x 10 x 35mm, 10° |
| 00190376615868 | IdentiTi II PC 7 x 10 x 30mm, 15° |
| 00190376615851 | IdentiTi II PC 7 x 10 x 30mm, 10° |
| 00190376615844 | IdentiTi II PC 7 x 10 x 30mm, 5° |
| 00190376615837 | IdentiTi II PC 7 x 10 x 25mm, 5° |
| 00190376615820 | IdentiTi II PC 6 x 10 x 35mm, 15° |
| 00190376615813 | IdentiTi II PC 6 x 10 x 35mm, 10° |
| 00190376615806 | IdentiTi II PC 6 x 10 x 30mm, 15° |
| 00190376615790 | IdentiTi II PC 6 x 10 x 30mm, 10° |
| 00190376615783 | IdentiTi II PC 6 x 10 x 30mm, 5° |
| 00190376615776 | IdentiTi II PC 6 x 10 x 25mm, 5° |
| 00190376599755 | ID II PC, INTRADISCAL DISTRACTOR TIP, 10mm |
| 00190376599748 | ID II PC, INTRADISCAL DISTRACTOR TIP, 9mm |
| 00190376599731 | ID II PC, INTRADISCAL DISTRACTOR TIP, 8mm |
| 00190376599724 | ID II PC, INTRADISCAL DISTRACTOR TIP, 7mm |
| 00190376599717 | ID II PC, INTRADISCAL DISTRACTOR TIP, 6mm |
| 00190376599700 | ID II PC, INTRADISCAL DISTRACTOR TIP, 5mm |