510(k) Report

Devices descending from K110419

9 later devices reach Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140088Phantom XL Insulated DilatorsTedan Surgical Innovations, LLC20142—
+1K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC)20145—
+2K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.20231—
+2K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+3K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…Tedan Surgical Innovations20260—
+3K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302