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FDA 510(k) Applications Submitted by Alex Underberg
FDA 510(k) Number
Submission Date
Device Name
Applicant
K210425
02/11/2021
Catalyft PL Expandable Interbody System
Medtronic Sofamor Danek, USA Inc.
K211441
05/10/2021
Navigated Anterolateral Disc Prep Instruments
Medtronic Sofamor Danek USA, INC.
K232340
08/04/2023
Arthrex 2.4mm Knotless Hip SutureTak« Suture Anchor
Arthrex Inc.
K223153
10/06/2022
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek USA, Inc.
K214011
12/22/2021
CatalyftÖ PL Expandable Interbody System Navigated Instruments, AnteralignÖ TL Spinal System with Titan nanoLOCKÖ Surface Technology Navigated Instruments, and CD HorizonÖ SoleraÖ VoyagerÖ Spinal System Navigated, Guided, and Powered Drivers
Medtronic Sofamor Danek USA, INC.
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