510(k) Report

Devices descending from K032578

12 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart201411—
+2K151695Romeo posterior osteosynthesis systemSpineart201510—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132