510(k) Report

Devices descending from K880215

9 later devices reach TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal Rod through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+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—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—