510(k) Report

Devices descending from K100757

9 later devices reach Tilock Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172469TiLock Modular Spinal SystemGenesys Spine20170—
+1K171838TiLock2 Spinal SystemGenesys Spine20174—
+1K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+1K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+1K103671Genesys Spine Tilock SystemGenesys Spine20118—
+2K252322SIros-X SystemGenesys Spine20250—
+2K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+3K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+4K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—