510(k) Report

Devices descending from K020085

3 later devices reach Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081631Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc.20081—
+1K043355Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model…Sintea Biotech, Inc.20042—
+2K112611Sintea Plustek PLS Multi-Axial ScrewsSintea Plastek, LLC20120—