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Medtronic Sofamor Danek

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories6
Latest Approval2021-12-13
TypeNumberDevice NameCodeDate
510(k) K212428 Centerpiece Plate Fixation System NQW 2021-12-13 View
510(k) K201267 Adaptix Interbody System with Titan nanoLOCK Surface Technology MAX 2020-08-26 View
510(k) K173125 T2 STRATOSPHERE™ Expandable Corpectomy System MQP 2017-12-20 View
510(k) K172199 ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium MAX 2017-09-19 View
510(k) K171031 CRESCENT™ Spinal System MAX 2017-07-06 View
510(k) K171468 FUSE Spinal System MAX 2017-06-13 View
510(k) K170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems NKB 2017-05-11 View
510(k) K161210 RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems OUR 2016-08-12 View
510(k) K153373 CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device ODP 2016-01-19 View