510(k) Report

Devices descending from K162199

7 later devices reach Cascade IOMAX Intraoperative Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+1K230415Cadwell GuardianCadwell Industries, Inc.20230—
+1K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+1K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+2K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+2K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+3K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302