510(k) Report

Devices descending from K052847

21 later devices reach Capless Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K090224Fortex Pedicle Screw SystemX-Spine Systems, Inc.20097—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K083743Capsure PS SystemSpine Wave, Inc.20093—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K172548Wiltrom Spinal Fixation SystemWiltrom Corporation Limited20181—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+2K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K202894Wiltrom Spinal Fixation SystemWiltrom Corporation Limited20200—
+3K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—