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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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