510(k) Report

Devices descending from K203506

3 later devices reach PERLA® TL posterior osteosynthesis system through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+2K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—