510(k) Report

Devices descending from K111127

13 later devices reach Romeo Posterior Osteosynthesis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+1K151695Romeo posterior osteosynthesis systemSpineart201510—
+1K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart201411—
+1K130267Romeo Posterior Osteosynthesis SystemSpineart201312—
+2K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+2K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+2K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+2K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132