510(k) Report

Devices descending from K132616

11 later devices reach EPAD through their predicates, nearest generation first.

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