510(k) Report

Devices descending from K172101

9 later devices reach ROMEO® 2 Posterior Osteosynthesis System through their predicates, nearest generation first.

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