The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Centurion Poct System.
| Device ID | K201481 |
| 510k Number | K201481 |
| Device Name: | Centurion POCT System |
| Classification | Posterior Cervical Screw System |
| Applicant | Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056 |
| Contact | Jacki Koch |
| Correspondent | Jacki Koch Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-04 |
| Decision Date | 2020-06-15 |