510(k) Report

Devices descending from K070281

28 later devices reach Issys LP Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113361Securis Spinal FixationCumtom Spine20120—
+1K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+1K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+1K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+2K080767Conquest Spinal SystemLife Spine200821—
+3K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K123373Nautilus Spinal SystemLife Spine201317—
+3K111953Nautilus Spinal SystemLife Spine20123—
+3K090320Conquest Spinal SystemLife Spine20092—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+4K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—