510(k) Report

Devices descending from K904926

18 later devices reach Smart-EP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070608Smartep, Model M010000Intelligent Hearing Systems200716—
+1K061443Smart Usblite, Model M011120Intelligent Hearing Systems20061—
+2K193033GSI Audera ProGrason Stadler20200—
+2K163326SmartEPIntelligent Hearing Systems20171—
+2K123843Neuroepg SystemStrohl Medical Technologies201312—
+2K083371Navigator Pro with Aep Software (Biomark, Enog, Champ)Natus Medical, Inc.20090—
+3K253301BraiN20® (BraiN20)Time IS Brain, S.L.20260—
+3K132616EPADSafeop Surgical, Inc.201411—
+4K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+5K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+6K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302