FDA 510(k) Applications Submitted by NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K191336 05/17/2019 PRECICE System NuVasive Specialized Orthopedics, Inc.
K170169 01/19/2017 PRECICE Intramedullary Limb Lengthening System NuVasive Specialized Orthopedics, Inc.
K172061 07/07/2017 PRECICE UNYTE System NuVasive Specialized Orthopedics, Inc.
K172628 09/01/2017 PRECICE System NuVasive Specialized Orthopedics, Inc.
K162927 10/19/2016 PRECICE UNYTE CoCr System NuVasive Specialized Orthopedics, Inc.
K200430 02/21/2020 Precice« Ankle Salvage System NuVasive Specialized Orthopedics, Inc.
K201543 06/09/2020 MAGEC« System NuVasive Specialized Orthopedics, Inc.
K170346 02/02/2017 PRECICE Intramedullary Limb Lengthening System NuVasive Specialized Orthopedics, Inc.
K160352 02/08/2016 MAGEC« Spinal Bracing and Distraction System NuVasive Specialized Orthopedics, Inc.
K180503 02/26/2018 PRECICE STRYDE System NuVasive Specialized Orthopedics, Inc.
K173129 09/29/2017 PRECICE System NuVasive Specialized Orthopedics, Inc.
K220234 01/27/2022 Precice Intramedullary Limb Lengthening System NuVasive Specialized Orthopedics, Inc.
K201567 06/11/2020 Precice« Bone Transport System NuVasive Specialized Orthopedics, Inc.
K192181 08/12/2019 PRECICE Plating System NuVasive Specialized Orthopedics, Inc.
K193016 10/29/2019 PRECICE Bone Transport System NuVasive Specialized Orthopedics, Inc.
K193617 12/26/2019 Precice« Screws NuVasive Specialized Orthopedics, Inc.
K230765 03/20/2023 Precice Ankle Salvage System NuVasive Specialized Orthopedics, Inc.
K202348 08/18/2020 External Remote Controller ERC 4P NuVasive Specialized Orthopedics, Inc.
K161751 06/24/2016 MAGEC« Spinal Bracing and Distraction System NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
K182170 08/10/2018 PRECICE« BONE TRANSPORTÖ System NuVasive Specialized Orthopedics, Inc.


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