510(k) Report

Devices descending from K171807

7 later devices reach ES2 Neuromonitoring Accessory Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+1K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+1K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+2K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+2K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+2K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+2K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—