FDA 510(k) Applications Submitted by Jacki Koch
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180025 |
01/03/2018 |
Centurion POCT System |
Orthofix Inc. |
| K180179 |
01/23/2018 |
Firebird« Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird« NXG Spinal Fixation System; Phoenix« Minimally Invasive Spinal Fixation System; Phoenix« CDXÖ Minimally Invasive Spinal Fixation System; JANUS« Midline Fixation Screw |
Orthofix Inc. |
| K170647 |
03/03/2017 |
Connector System |
Orthofix Inc. |
| K210667 |
03/05/2021 |
FIREBIRD SI Fusion System |
Orthofix Inc. |
| K200696 |
03/17/2020 |
FIREBIRD SI Fusion System |
Orthofix Inc. |
| K190751 |
03/25/2019 |
Connector System |
Orthofix Inc. |
| K171082 |
04/11/2017 |
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System |
Orthofix Inc. |
| K211704 |
06/03/2021 |
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervica |
Orthofix Inc. |
| K211710 |
06/03/2021 |
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 Screw |
Orthofix Inc. |
| K211712 |
06/03/2021 |
3░ Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System |
Orthofix US LLC |
| K201481 |
06/04/2020 |
Centurion POCT System |
Orthofix Inc. |
| K201664 |
06/19/2020 |
FIREBIRD SI Fusion System |
Orthofix Inc. |
| K172115 |
07/13/2017 |
Navigated Instrument System |
Orthofix Inc. |
| K172194 |
07/21/2017 |
Connector System |
Orthofix Inc. |
| K162446 |
09/01/2016 |
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System |
ORTHOFIX INC. |
| K162638 |
09/22/2016 |
CETRA Anterior Cervical Plate System |
Orthofix Inc. |
| K162921 |
10/18/2016 |
Navigated Instrument System |
ORTHOFIX INC. |
| K203138 |
10/20/2020 |
FIREBIRD SI Fusion System |
Orthofix Inc. |
| K183342 |
12/03/2018 |
SambaScrew 3D SI Fusion System |
Orthofix Inc. |
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