510(k) Report

Devices descending from K213849

4 later devices reach SafeOp 2: Neural Informatix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+2K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+2K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—