510(k) Report

Devices descending from K934779

14 later devices reach Agram Spyral Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050194Axon Systems Subdermal Needle ElectrodesAxon Systems, Inc.200513—
+2K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—
+2K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleBionen S.A.S.20101—
+2K073229Nerve Monitoring CablePioneer Surgical Technology20085—
+2K072276Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd.20085—
+3K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.20230—
+3K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+3K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe201332
+4K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe20240—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.20160—
+5K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302