Orthofix, Inc. · Class II · Cleared Jul 30, 2021
| K-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 Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System |
| Applicant | Orthofix, Inc. |
| Product code | NKG |
| Device class | Class II |
| Decision date | Jul 30, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 888.3075 |
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