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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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