Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K221050
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System · Aegis Spine, Inc. · decided 2022-06-30 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Paeon Posterior Cervical Fixation System | 6142-3169S | Aegis Spine, Inc. | NKG | 00840273318422 |
| Paeon Posterior Cervical Fixation System | 6139-3545S | Aegis Spine, Inc. | NKG | 00840273317746 |
| Paeon Posterior Cervical Fixation System | 6126-51025S | Aegis Spine, Inc. | NKG | 00840273316893 |
| Paeon Posterior Cervical Fixation System | 6125-41535S | Aegis Spine, Inc. | NKG | 00840273316732 |
| Paeon Posterior Cervical Fixation System | 6121-3515S | Aegis Spine, Inc. | NKG | 00840273315926 |
| Paeon Posterior Cervical Fixation System | 6116-3546S | Aegis Spine, Inc. | NKG | 00840273314530 |
| Paeon Posterior Cervical Fixation System | 6115-3512S | Aegis Spine, Inc. | NKG | 00840273313526 |
| Paeon Posterior Cervical Fixation System | 6112-4026S | Aegis Spine, Inc. | NKG | 00840273313380 |
| Paeon Posterior Cervical Fixation System | 6122-3506S | Aegis Spine, Inc. | NKG | 00840273316251 |
| Paeon Posterior Cervical Fixation System | 6118-3548S | Aegis Spine, Inc. | NKG | 00840273315261 |
| Paeon Posterior Cervical Fixation System | 6142-2158S | Aegis Spine, Inc. | NKG | 00840273318149 |
| Paeon Posterior Cervical Fixation System | 6121-3517S | Aegis Spine, Inc. | NKG | 00840273315940 |
| Paeon Posterior Cervical Fixation System | 6121-3505S | Aegis Spine, Inc. | NKG | 00840273315827 |
| Paeon Posterior Cervical Fixation System | 6116-3550S | Aegis Spine, Inc. | NKG | 00840273314554 |
| Paeon Posterior Cervical Fixation System | 6113-4046S | Aegis Spine, Inc. | NKG | 00840273314325 |
| Paeon Posterior Cervical Fixation System | 6114-3544S | Aegis Spine, Inc. | NKG | 00840273312840 |
| Paeon Posterior Cervical Fixation System | 6202-5550 | Aegis Spine, Inc. | NKG | 00840273319078 |
| Paeon Posterior Cervical Fixation System | 6142-3269S | Aegis Spine, Inc. | NKG | 00840273318514 |
| Paeon Posterior Cervical Fixation System | 6142-1040S | Aegis Spine, Inc. | NKG | 00840273317982 |
| Paeon Posterior Cervical Fixation System | 6134-3565S | Aegis Spine, Inc. | NKG | 00840273317470 |
| Paeon Posterior Cervical Fixation System | 6121-3510S | Aegis Spine, Inc. | NKG | 00840273315872 |
| Paeon Posterior Cervical Fixation System | 6112-4040S | Aegis Spine, Inc. | NKG | 00840273313458 |
| Paeon Posterior Cervical Fixation System | 6201-5050 | Aegis Spine, Inc. | NKG | 00840273318798 |
| Paeon Posterior Cervical Fixation System | 6201-5045 | Aegis Spine, Inc. | NKG | 00840273318781 |
| Paeon Posterior Cervical Fixation System | 6134-3580S | Aegis Spine, Inc. | NKG | 00840273317487 |