510(k) Report

Devices descending from K142146

5 later devices reach Ibis Pedicle Screw System through their predicates, nearest generation first.

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