Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Novel | 64636-008 | ALPHATEC SPINE, INC. | MAX | 00844856030602 |
| Novel | 64636-112 | ALPHATEC SPINE, INC. | MAX | 00844856028012 |
| Novel Spinal Spacer System | 64353-346 | ALPHATEC SPINE, INC. | MAX MQP | 00844856012363 |
| Novel Spinal Spacer System | 64351-344 | ALPHATEC SPINE, INC. | MAX MQP | 00844856012059 |
| Novel Spinal Spacer System | 64351-148 | ALPHATEC SPINE, INC. | MAX MQP | 00844856011953 |
| Novel | 64115-008 | ALPHATEC SPINE, INC. | MAX MQP | 00844856008908 |
| Novel | 64887-015 | ALPHATEC SPINE, INC. | ODP | 00844856034556 |
| Novel | 64895-011 | ALPHATEC SPINE, INC. | ODP | 00844856031388 |
| Novel | 64618-113 | ALPHATEC SPINE, INC. | MAX MQP | 00844856014091 |
| Novel Spinal Spacer System | 64335-434 | ALPHATEC SPINE, INC. | MAX MQP | 00844856011823 |
| Novel Spinal Spacer System | 64335-136 | ALPHATEC SPINE, INC. | MAX MQP | 00844856011595 |
| Novel Spinal Spacer System | 64331-332 | ALPHATEC SPINE, INC. | MAX MQP | 00844856010932 |
| Novel Spinal Spacer System | 64331-228 | ALPHATEC SPINE, INC. | MAX MQP | 00844856010833 |
| Novel Spinal Spacer System | 64311-420 | ALPHATEC SPINE, INC. | MAX MQP | 00844856009929 |
| Novel Spinal Spacer System | 64311-416 | ALPHATEC SPINE, INC. | MAX MQP | 00844856009905 |
| Novel Spinal Spacer System | 64311-414 | ALPHATEC SPINE, INC. | MAX MQP | 00844856009899 |
| Novel | 64106-108 | ALPHATEC SPINE, INC. | MAX MQP | 00844856008700 |
| Novel | 64103-012 | ALPHATEC SPINE, INC. | MAX MQP | 00844856008441 |
| Novel | 64679-107 | ALPHATEC SPINE, INC. | MAX | 00840967192406 |
| Novel Spinal Spacer System | 64817-017 | ALPHATEC SPINE, INC. | MAX MQP | 00844856066540 |
| Novel Spinal Spacer System | 64837-010 | ALPHATEC SPINE, INC. | MAX MQP | 00844856031227 |
| Novel | 64637-010 | ALPHATEC SPINE, INC. | MAX | 00844856030701 |
| Novel | 64815-009 | ALPHATEC SPINE, INC. | MAX MQP | 00844856019379 |
| Novel | 64807-013 | ALPHATEC SPINE, INC. | MAX MQP | 00844856019270 |
| Novel | 64618-108 | ALPHATEC SPINE, INC. | MAX MQP | 00844856014046 |