510(k) Report

Devices descending from K992348

4 later devices reach Synthes Spiral Blade for Humeral Nail (SBHN) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—