510(k) Report

Devices descending from K011067

11 later devices reach Modification to TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—