Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K211111
SureMAX-SA Cervical Standalone System · Additive Implants, Inc. · decided 2021-07-16 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | LYQ | 00817662026008 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025353 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025513 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025216 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | LYQ | 00817662027180 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | LYQ | 00817662025834 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662024967 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | LYQ | 00817662025858 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | LYQ | 00817662025773 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025681 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025643 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025148 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662024851 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025605 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025162 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662026312 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025438 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025650 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025537 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025193 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025063 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025087 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025520 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662024813 |
| SureMAX-SA | 1 | ADDITIVE IMPLANTS, LLC | OVE | 00817662025018 |