510(k) Report

Devices descending from K211757

3 later devices reach Simplify Disc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220861M6-C Artificial Cervical Disc Instruments ASSpinal Kinetics, LLC20222—
+2K241117M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine20240—
+2K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC20230—