510(k) Report

Devices descending from K093304

20 later devices reach Protektor 32 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190703Neuro-IOM system with Neuro-IOM.NET softwareNeurosoft, Ltd.20211—
+1K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+1K132616EPADSafeop Surgical, Inc.201411—
+2K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+2K253301BraiN20® (BraiN20)Time IS Brain, S.L.20260—
+2K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)Soterix Medical, Inc.20240—
+2K230415Cadwell GuardianCadwell Industries, Inc.20230—
+2K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+2K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+2K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+3K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+3K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+3K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+3K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+4K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+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
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—