510(k) Report

Devices descending from K905184

10 later devices reach Isola (TM) Spine System Top Entry Hook through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—