510(k) Report

Devices descending from K182542

9 later devices reach The EPAD 2 System through their predicates, nearest generation first.

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