FDA 510(k) Applications Submitted by NATALIA VOLOSEN

FDA 510(k) Number Submission Date Device Name Applicant
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.
K121649 06/05/2012 CONSTRUX MINI PEEK TI SPACER SYSTEM ORTHOFIX
K142152 08/06/2014 CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, 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.
K143028 10/21/2014 Azure Anterior Cervical Plate System ORTHOFIX, INC.
K203342 11/13/2020 CONSTRUX Mini Ti Spacer System Orthofix Inc.
K203576 12/07/2020 FORZA Ti Spacer System Orthofix Inc.
K213951 12/17/2021 FORZA XP Expandable Spacer System Orthofix US LLC


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