FDA 510(k) Applications Submitted by NEXTREMITY SOLUTIONS, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K200785 03/26/2020 StratumÖ Reduced Size Foot Plating System Nextremity Solutions, Inc.
K182201 08/14/2018 StratumÖ Foot Plating System Nextremity Solutions, Inc.
K200124 01/21/2020 InCore MPJ System Nextremity Solutions, Inc.
K220181 01/21/2022 StealthFix Intraosseous Fixation System Nextremity Solutions, Inc.
K200840 03/31/2020 DuoHex CH Cannulated Hammertoe System Nextremity Solutions, Inc.
K221610 06/03/2022 Nextra CH Cannulated Hammertoe System Nextremity Solutions, Inc.
K211996 06/28/2021 Nexta PEEK Hammertoe Correction System Nextremity Solutions, Inc.
K212640 08/20/2021 Stratum« Ankle Fusion Plating System Nextremity Solutions, Inc.
K212979 09/17/2021 CalcShiftÖ Displacement Calcaneal Osteotomy System Nextremity Solutions, Inc.
K192578 09/19/2019 InCore TMT System Nextremity Solutions, Inc.
K213301 10/01/2021 InCore Subtalar System Nextremity Solutions, Inc.
K213530 11/05/2021 Nextra CH Cannulated Hammertoe System Nextremity Solutions, Inc.
K180257 01/30/2018 InCore« Lapidus System Nextremity Solutions, Inc.
K190231 02/06/2019 InCore« Lapidus Sterile Kits Nextremity Solutions, Inc.
K140724 03/21/2014 MSP METATARSAL SHORTENING SYSTEM NEXTREMITY SOLUTIONS, INC.
K151160 05/01/2015 Arcus Staple System NEXTREMITY SOLUTIONS, INC.
K152548 09/08/2015 AXI+LINE Proximal Bunion Correction System NEXTREMITY SOLUTIONS, Inc.


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