Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Novel Spinal Spacer System | 64767-105 | ALPHATEC SPINE, INC. | ODP | 00844856045132 |
| Novel | 64797-009 | ALPHATEC SPINE, INC. | ODP | 00844856028425 |
| Novel | 64715-111 | ALPHATEC SPINE, INC. | ODP | 00844856016132 |
| Novel | 64797-009-11 | ALPHATEC SPINE, INC. | ODP | 00190376076423 |
| Novel | 64793-009-11 | ALPHATEC SPINE, INC. | ODP | 00190376076140 |
| Novel | 64797-007 | ALPHATEC SPINE, INC. | ODP | 00844856028401 |
| Novel | 64795-005 | ALPHATEC SPINE, INC. | ODP | 00844856028265 |
| Novel | 64793-106 | ALPHATEC SPINE, INC. | ODP | 00844856028210 |
| Novel | 64717-005 | ALPHATEC SPINE, INC. | ODP | 00844856016347 |
| Novel | 64715-007 | ALPHATEC SPINE, INC. | ODP | 00844856015890 |
| Novel | 64795-010-11 | ALPHATEC SPINE, INC. | ODP | 00190376076294 |
| Novel | 64764-111 | ALPHATEC SPINE, INC. | ODP | 00844856065864 |
| Novel | CI-10305-20-108 | ALPHATEC SPINE, INC. | ODP | 00811801037092 |
| Novel | 64717-010 | ALPHATEC SPINE, INC. | ODP | 00844856016392 |
| Novel | 64793-105-11 | ALPHATEC SPINE, INC. | ODP | 00190376076171 |
| Novel | 64768-110 | ALPHATEC SPINE, INC. | ODP | 00844856066052 |
| Novel | CI-10317-20-10 | ALPHATEC SPINE, INC. | ODP | 00811801034510 |
| Novel | 64713-006 | ALPHATEC SPINE, INC. | ODP | 00844856015470 |
| Novel Spinal Spacer System | 64767-107 | ALPHATEC SPINE, INC. | ODP | 00844856045156 |
| Novel | 64715-010 | ALPHATEC SPINE, INC. | ODP | 00844856015920 |
| Novel | 64766-109 | ALPHATEC SPINE, INC. | ODP | 00844856065949 |
| Novel | 64901-112 | ALPHATEC SPINE, INC. | ODP | 00844856034709 |
| Novel | 64797-106 | ALPHATEC SPINE, INC. | ODP | 00844856028456 |
| Novel | 64797-109-11 | ALPHATEC SPINE, INC. | ODP | 00190376076492 |
| Novel | 64795-105-11 | ALPHATEC SPINE, INC. | ODP | 00190376076317 |