510(k) Report

Devices descending from K053418

25 later devices reach Synthes OC Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC200921—
+1K072434Synthes OC Fusion and Synapse SystemsSynthes Spine Co.Lp20082—
+2K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC20210—
+2K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+2K173047The Solstice OCT SystemLife Spine, Inc.20180—
+2K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K090549Synthes Synapse TransconnectorSynthes Spine20091—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K200896Solstice CCILife Spine, Inc.20200—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—