510(k) Report

Devices descending from K961213

7 later devices reach Alta Dome and Plunger (Mec Hip Bolt) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC201602
+1K102528N-Force Fixation SystemInnovision, Inc.20115—
+2K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+2K151146N-Force Fixation SystemInnovision, Inc.20151—
+2K142776Flow-ScrewFlow-Fx, LLC20151—
+2K132244N-Force Fixation SystemInnovision, Inc.20143—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—