Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Novel | 64405-416 | ALPHATEC SPINE, INC. | MAX | 00844856033924 |
| Novel | 64925-212 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035164 |
| Novel | 64923-212 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035041 |
| Novel | 64403-414 | ALPHATEC SPINE, INC. | MAX | 00844856033818 |
| Novel | 64401-418 | ALPHATEC SPINE, INC. | MAX | 00844856033719 |
| Novel | 64923-218 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035072 |
| Novel | 64403-412 | ALPHATEC SPINE, INC. | MAX | 00844856033801 |
| Novel | 64927-414 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035324 |
| Novel | 64405-218 | ALPHATEC SPINE, INC. | MAX | 00844856033887 |
| Novel | 64927-216 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035294 |
| Novel | 64923-410 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035096 |
| Novel | 64403-220 | ALPHATEC SPINE, INC. | MAX | 00844856038325 |
| Novel | 64403-418 | ALPHATEC SPINE, INC. | MAX | 00844856033832 |
| Novel | 64923-216 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035065 |
| Novel | 64927-214 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035287 |
| Novel | 64403-410 | ALPHATEC SPINE, INC. | MAX | 00844856033795 |
| Novel | 64401-410 | ALPHATEC SPINE, INC. | MAX | 00844856033672 |
| Novel | 64923-214 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035058 |
| Novel | 64925-214 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035171 |
| Novel | 64920 | ALPHATEC SPINE, INC. | MAX MQP | 00844856034884 |
| Novel | 64405-216 | ALPHATEC SPINE, INC. | MAX | 00844856033870 |
| Novel | 64405-212 | ALPHATEC SPINE, INC. | MAX | 00844856033856 |
| Novel | 64401-212 | ALPHATEC SPINE, INC. | MAX | 00844856033627 |
| Novel | 64923-210 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035034 |
| Novel | 64927-210 | ALPHATEC SPINE, INC. | MAX MQP | 00844856035263 |