510(k) Report

Devices descending from K053394

9 later devices reach Nexa Bone Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc.20170—
+1K150871ForeFoot STP SystemTornier, Inc.20150—
+1K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+1K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+1K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc.20065—
+2K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+2K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+2K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—