The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Ascent Poct System, Centurion Poct System, Spinal Fixation System (sfs), Firebird Spinal Fixation Systems: (firebird Deformity Spinal Fixation System, Phoenix Mis Spinal Fixation System, Phoenix Cdx Mis Spinal Fixation System, Janus Midline Fixation .
| Device ID | K211710 |
| 510k Number | K211710 |
| Device Name: | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation |
| 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 |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | NKB |
| Subsequent Product Code | OUR |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-03 |
| Decision Date | 2021-07-30 |