510(k) Report

Devices descending from K212166

5 later devices reach ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+1K230415Cadwell GuardianCadwell Industries, Inc.20230—
+1K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+2K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+2K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302