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FDA 510(k) Applications Submitted by Elizabeth Hamilton
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190840
04/01/2019
Medtronic Transportation / Sterilization Cassettes
Medtronic Sofamor Danek USA, INC.
K191039
04/19/2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
Medtronic Sofamor Danek, USA Inc
K221180
04/25/2022
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments
Medtronic Sofamor Danek USA, INC
K222383
08/05/2022
AnteralignÖ LS Spinal System with Titan nanoLOCKÖ Surface Technology MAZORX Stealth(TM) Edition
Medtronic Sofamor Danek USa, Inc.
K212524
08/11/2021
Anteralign Spinal System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek USA, INC.
K183510
12/18/2018
T2 STRATOSPHERE Expandable Corpectomy System
Medtronic Sofamor Danek, USA Inc.
K214010
12/22/2021
Anteralign Spinal System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek USA
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