510(k) Report

Devices descending from K203222

4 later devices reach PERLA TL Posterior Osteosynthesis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+1K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+1K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—