510(k) Report

Devices descending from K043355

2 later devices reach Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081631Sintea Biotech PLS Multi-Axial ScrewsSintea Biotech, Inc.20081—
+2K112611Sintea Plustek PLS Multi-Axial ScrewsSintea Plastek, LLC20120—