510(k) Report

Devices descending from K123843

12 later devices reach Neuroepg System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253301BraiN20® (BraiN20)Time IS Brain, S.L.20260—
+1K132616EPADSafeop Surgical, Inc.201411—
+2K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+3K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+3K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+4K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302