510(k) Report

Devices descending from K012105

149 later devices reach Polyvac Surgical Instrument Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160912Sterilization TraySTERIS Corporation20166—
+4K151347MIS Spine Frame Instrument CaseThompson Surgical Instruments20150—
+4K143579NuVasive Sterilization TraysNu Vasive, Incorporated20153—
+5K243425Guided DAS Surgical KitTalladium España, SL20250—
+5K241927Synthes Graphic Case & Tray SystemSynthes GmbH20251—
+5K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant…Prismatik Dentalcraft, Inc.20250—
+5K243317NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd.20250—
+5K241050CrossRoads Modular Tray SystemCrossroads Extremity Systems20240—
+5K230804Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+5K231219NobelZygoma PureSet™ TrayNobel Biocare Services AG20230—
+5K212281Surgical TraysDentsply Sirona, Inc.20225—
+5K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Nobel Biocare Services AG20212—
+5K203753Straumann Surgical CassettesStraumann USA, LLC20211—
+5K211007EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC20211—
+5K201412BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO…Bego Implant Systems GmbH & Co. KG20210—
+5K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+5K201688S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20204—
+5K192670Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+5K191522Straumann Modular CassetteInstitut Straumann AG20192—
+5K181845Pivot System Sterilization caseRp Medical, Inc.20190—
+5K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray…Nobel Biocare AB20194—
+5K183701Stryker ChestShield Sterilization Tray SystemParagon Medical20190—
+5K173391OsteoMed QuickFix Hybrid MMF Sterilization TrayOsteomed, LLC20182—
+5K172755PRO-LITE Sterilization TraysSTERIS Corporation20185—
+6K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG20260—
+6K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.20260—
+6K241378S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K231144WashtraysDentsply Sirona20240—
+6K233264Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr20230—
+6K223662Neodent Implant System - Helix Short Surgical Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K223672Instrument Case P1340904Cochlear20231—
+6K222514S.I.N. Instrument KitsS.I.N. – Sistema DE Implante Nacional S.A.20220—
+6K222005S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20220—
+6K220791Surgical and Prosthetic TraysDentsply Sirona20222—
+6K214051Neodent Implant System-Helix NGM Compact Surgical Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20220—
+6K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceK1 Medical, LLC20210—
+6K212404S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20211—
+6K203618Neodent EasyGuide Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20211—
+6K202515NUVO Implant System – NUVO Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K202105OsteoMed ExtremiFix Mini & Small System TrayOsteomed, LLC20200—
+6K183402PRO-LITE Sterilization TraySTERIS Corporation20193—
+6K183301PRO-LITE Sterilization TraySTERIS Corporation20190—
+7K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.20260—
+7K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.20260—
+7K241492Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20240—
+7K231604Instrument CaseCochlear Americas20230—
+7K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris20222—
+8K231501PRO-LITE Sterilization TraySTERIS Corporation20230—
+8K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation20230—