510(k) Report

Devices descending from K070608

16 later devices reach Smartep, Model M010000 through their predicates, nearest generation first.

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