510(k) Report

Devices descending from K102331

6 later devices reach LDR Spine Usa Spinetune TL Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+1K120760LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc.20124—
+2K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—