| Primary Device ID | 00190376159812 |
| NIH Device Record Key | 7d3daff6-b927-4119-a631-40e8672fba07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATEC Porous Ti Interbody System |
| Version Model Number | 94237-120-02 |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 00190376159812 [Primary] |
| PHM | Intervertebral fusion device with bone graft, thoracic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
[00190376159812]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-10 |
| Device Publish Date | 2020-03-02 |
| 00190376160580 | PO Offset Inserter |
| 00190376159812 | PO Inserter, 10 mm Bolstered Sleeve |
| 00190376159805 | PO Inserter, 12 mm Impaction Sleeve |
| 00190376151182 | PO Inserter, 10 mm Impaction Sleeve |
| 00190376151175 | PO Inserter |
| 00190376151137 | PO Trial, 12P x 13A x 12W x 30L , 5° |
| 00190376151120 | PO Trial, 10P x 11A x 12W x 30L , 5° |
| 00190376151113 | PO Trial, 8P x 9A x 12W x 30L , 5° |
| 00190376148953 | PO Trial, 12P x 14A x 10W x 30L , 10° |
| 00190376148946 | PO Trial, 10P x 12A x 10W x 30L , 10° |
| 00190376148939 | PO Trial, 8P x 10A x 10W x 30L , 10° |
| 00190376148922 | PO Trial, 12P x 13A x 10W x 30L , 5° |
| 00190376148915 | PO Trial, 10P x 11A x 10W x 30L , 5° |
| 00190376148908 | PO Trial, 8P x 9A x 10W x 30L , 5° |
| 00190376148892 | PO Trial, 12P x 14A x 10W x 25L , 10° |
| 00190376148885 | PO Trial, 10P x 12A x 10W x 25L , 10° |
| 00190376148878 | PO Trial, 8P x 10A x 10W x 25L , 10° |
| 00190376148861 | PO Trial, 12P x 13A x 10W x 25L , 5° |
| 00190376148854 | PO Trial, 10P x 11A x 10W x 25L , 5° |
| 00190376148847 | PO Trial, 8P x 9A x 10W x 25L , 5° |
| 00190376146591 | ATEC POROUS Ti PC, INSERTER, OFFSET |
| 00190376146577 | ATEC POROUS Ti PC, INSERTER, AXIAL |
| 00190376116532 | ATEC Porous Ti PS, Inserter, Offset |
| 00190376116518 | ATEC Porous Ti PS, Inserter, Axial |
| 00190376116389 | PC Trial, 9 x 10 x 30 mm - 15° |
| 00190376116365 | PC Trial, 7 x 10 x 30 mm - 15° |
| 00190376116266 | PC Trial, 10 x 10 x 30 mm - 10° |
| 00190376116259 | PC Trial, 9 x 10 x 30 mm - 10° |
| 00190376116242 | PC Trial, 8 x 10 x 30 - 10° |
| 00190376116235 | PC Trial, 7 x 10 x 30 - 10° |
| 00190376116136 | PC Trial, 11 x 10 x 30 - 5° |
| 00190376116129 | PC Trial, 10 x 10 x 30 - 5° |
| 00190376116112 | PC Trial, 9 x 10 x 30 - 5° |
| 00190376116105 | PC Trial, 8 x 10 x 30 - 5° |
| 00190376102887 | Cervical Trial, 12 x 22 x 19 - 15° |
| 00190376102870 | Cervical Trial, 12 x 22 x 19 - 12° |
| 00190376102863 | Cervical Trial, 12 x 22 x 19 - 10° |
| 00190376102856 | Cervical Trial, 12 x 22 x 19 - 7° |
| 00190376102849 | Cervical Trial, 12 x 22 x 19 - 5° |
| 00190376102832 | Cervical Trial, 12 x 22 x 19 - 0° |
| 00190376102825 | Cervical Trial, 12 x 20 x 18 - 15° |
| 00190376102818 | Cervical Trial, 10 x 22 x 19 - 5° |
| 00190376102801 | Cervical Trial, 10 x 22 x 19 - 0° |
| 00190376102795 | Cervical Trial, 10 x 20 x 18 - 15° |
| 00190376102788 | Cervical Trial, 10 x 20 x 18 - 12° |
| 00190376102771 | Cervical Trial, 10 x 20 x 18 - 10° |
| 00190376102764 | Cervical Trial, 10 x 20 x 18 - 7° |
| 00190376102757 | Cervical Trial, 10 x 20 x 18 - 5° |
| 00190376102740 | Cervical Trial, 10 x 20 x 18 - 0° |
| 00190376102733 | Cervical Trial, 10 x 18 x 16 - 15° |