510(k) Report

Devices descending from K063166

9 later devices reach I.T.S. Pelvic Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+1K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+1K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+1K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—