510(k) Report

Devices descending from K131785

6 later devices reach Pagoda Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203023Pisces Spinal SystemOrtho Development Corporation20210—
+1K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+1K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+2K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—