Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K153603
Alphatec Navigation Instruments · Alphatec Spine, Inc. · decided 2016-04-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Invictus | 17085-035-N | ALPHATEC SPINE, INC. | OLO | 00190376319087 |
| Arsenal | 87551-70 | ALPHATEC SPINE, INC. | OLO | 00190376002781 |
| Invictus | 17413-38-N | ALPHATEC SPINE, INC. | OLO | 00190376383415 |
| Invictus | 17139-075-N | ALPHATEC SPINE, INC. | OLO | 00190376319261 |
| Invictus | 16421 | ALPHATEC SPINE, INC. | OLO | 00190376239699 |
| Arsenal | 87551-50 | ALPHATEC SPINE, INC. | OLO | 00190376002705 |
| Invictus | 17085-035 | ALPHATEC SPINE, INC. | OLO | 00190376281612 |
| Invictus | 17039-115 | ALPHATEC SPINE, INC. | OLO | 00190376234908 |
| Arsenal | 87777-055 | ALPHATEC SPINE, INC. | OLO | 00190376003115 |
| Invictus | 17833-041-N | ALPHATEC SPINE, INC. | OLO | 00190376475745 |
| Invictus | 17139-115 | ALPHATEC SPINE, INC. | OLO | 00190376235158 |
| Arsenal | CI-10091 | ALPHATEC SPINE, INC. | OLO | 00811801031113 |
| Invictus | 17420 | ALPHATEC SPINE, INC. | OLO | 00190376284255 |
| Invictus | 17041 | ALPHATEC SPINE, INC. | OLO | 00190376195896 |
| Arsenal | 87771 | ALPHATEC SPINE, INC. | OLO | 00190376002965 |
| Invictus | 17413-31-N | ALPHATEC SPINE, INC. | OLO | 00190376383392 |
| Invictus | 17039-100-N | ALPHATEC SPINE, INC. | OLO | 00190376319049 |
| Invictus | 17085-055 | ALPHATEC SPINE, INC. | OLO | 00190376281674 |
| Invictus | 17039-045-N | ALPHATEC SPINE, INC. | OLO | 00190376318936 |
| Arsenal | 87781 | ALPHATEC SPINE, INC. | OLO | 00190376003702 |
| Arsenal | 87551-60 | ALPHATEC SPINE, INC. | OLO | 00190376002743 |
| Invictus | 17139-125-N | ALPHATEC SPINE, INC. | OLO | 00190376319407 |
| Invictus | 17085-048-N | ALPHATEC SPINE, INC. | OLO | 00190376319124 |
| Invictus | 17039-095 | ALPHATEC SPINE, INC. | OLO | 00190376235219 |
| Invictus | 17085-066-N | ALPHATEC SPINE, INC. | OLO | 00190376319179 |