FDA 510(k) Applications Submitted by ORTHOFIX INC.

FDA 510(k) Number Submission Date Device Name Applicant
K121658 06/05/2012 ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) ORTHOFIX INC.
K111183 04/27/2011 ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS) ORTHOFIX INC.
K103111 10/21/2010 FORZA SPACER SYSTEM ORTHOFIX INC.
K153428 11/25/2015 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System ORTHOFIX INC.
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.
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.
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.
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.
K110805 03/23/2011 GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) ORTHOFIX INC.
K102201 08/04/2010 CONTOURS LAPIDUS PLATING SYSTEM ORTHOFIX INC.
K093442 11/05/2009 GUIDED GROWTH SYSTEM ORTHOFIX INC.
K200052 01/10/2020 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System Orthofix Inc.
K150619 03/10/2015 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System Orthofix Inc.
K161129 04/21/2016 PILLAR SA PTC ORTHOFIX INC.
K161280 05/06/2016 Cervical Stand Alone System Orthofix Inc.
K172437 08/11/2017 CONSTRUX« Mini PTC Spacer System, FORZA« PTC Spacer System, PILLAR« SA PTC Spacer System Orthofix Inc.
K152475 08/31/2015 FORZA PTC Spacer System ORTHOFIX INC.
K172696 09/07/2017 FORZA« XP Expandable Spacer System Orthofix Inc.
K202666 09/14/2020 CONSTRUX Mini PTC Spacer System Orthofix Inc.
K132999 09/24/2013 CERVICAL STAND ALONE SYSTEM ORTHOFIX INC.
K202949 09/30/2020 CONSTRUX Mini PEEK Spacer System Orthofix Inc.
K203342 11/13/2020 CONSTRUX Mini Ti Spacer System Orthofix Inc.
K203576 12/07/2020 FORZA Ti Spacer System Orthofix Inc.
K101812 06/29/2010 CONSTRUX MINI PEEK SPACER SYSTEM ORTHOFIX INC.
K140260 02/03/2014 SKYHAWK LATERAL PLATE SYSTEM ORTHOFIX INC.
K140709 03/21/2014 SKYHAWK INTERBODY FUSION SYSTEM ORTHOFIX INC.


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