510(k) Report

Devices descending from K141835

11 later devices reach Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent Rods through their predicates, nearest generation first.

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