FDA 510(k) Applications Submitted by Greg Kowalczyk

FDA 510(k) Number Submission Date Device Name Applicant
K170214 01/24/2017 Additive Orthopaedics Locking Lattice Plate Additive Orthopaedics, LLC
K160264 02/02/2016 Additive Orthopaedics Hammertoe Correction System Additive Orthopaedics, LLC
K211076 04/12/2021 Patient Specific Marking Guides Additive Orthopaedics, LLC
K223227 10/18/2022 MAVENÖ Patient-Specific Instrumentation Paragon 28, Inc
K180239 01/29/2018 Additive Orthopaedics Patient Specific 3D Printed Bone Segments Additive Orthopaedics, LLC
K183011 10/31/2018 Additive Orthopaedics Patient Specific 3D Locking Lattice Plates Additive Orthopaedics
K153207 11/05/2015 Additive Orthopaedics Bone Wedge System Additive Orthopaedics, LLC
K163593 12/21/2016 Additive Orthopaedics Bunion System Additive Orthopaedics, LLC.


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