510(k) Report

Devices descending from K091266

15 later devices reach Theken Coral Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120047Coral Spinal SystemTheken Spine, LLC201214—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+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—