510(k) Report

Devices descending from K993535

130 later devices reach Metapak Multi-Purpose Instrument Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+5K202268CrossRoads Tray SystemCrossroads Extremity Systems, LLC20203—
+5K190665Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K182865Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A.201913—
+5K172755PRO-LITE Sterilization TraysSTERIS Corporation20185—
+6K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.20260—
+6K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.20260—
+6K243425Guided DAS Surgical KitTalladium España, SL20250—
+6K241927Synthes Graphic Case & Tray SystemSynthes GmbH20251—
+6K243317NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd.20250—
+6K241050CrossRoads Modular Tray SystemCrossroads Extremity Systems20240—
+6K231604Instrument CaseCochlear Americas20230—
+6K230804Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K201688S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20204—
+6K192670Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+6K183402PRO-LITE Sterilization TraySTERIS Corporation20193—
+6K183301PRO-LITE Sterilization TraySTERIS Corporation20190—
+7K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.20260—
+7K241378S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K223662Neodent Implant System - Helix Short Surgical Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+7K222514S.I.N. Instrument KitsS.I.N. – Sistema DE Implante Nacional S.A.20220—
+7K222005S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20220—
+7K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris20222—
+7K214051Neodent Implant System-Helix NGM Compact Surgical Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20220—
+7K212404S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20211—
+7K203618Neodent EasyGuide Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20211—
+7K202515NUVO Implant System – NUVO Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+8K241492Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20240—
+8K231501PRO-LITE Sterilization TraySTERIS Corporation20230—
+8K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation20230—