510(k) Report

Devices descending from K081414

21 later devices reach Modification to Coral Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120047Coral Spinal SystemTheken Spine, LLC201214—
+1K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+1K100970Stainless Steel Spinal SystemTheken Spine, LLC20101—
+1K091266Theken Coral Spinal SystemTheken Spine, LLC200915—
+2K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K120829Stainless Steel Spinal SystemTheken Spine, LLC20120—
+3K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+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—