510(k) Report

Devices descending from K993854

16 later devices reach Ora-50 S Autotemp Electrothermal Spine System and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+1K033981Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc.200414—
+2K161661Thermi RF AccessoriesThermi20163—
+2K130689Symphony RF GeneratorThermigen, Inc.201311—
+2K063489Stryker Intradiscal RF GeneratorSynergetics, Inc.20070—
+2K063480Stryker RF Intradiscal Adaptor, Model 406-750Stryker Corp.20070—
+3K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+3K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+3K170116Thermi Injectable RF ElectrodesThermi20172—
+3K151793InMode RF SystemInmode MD, Ltd.20161—
+4K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+4K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+4K163190InMode RF SystemInmode MD, Ltd.20160—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+6K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—