510(k) Report

Devices descending from K131455

30 later devices reach Restore Modular Sterilization Tray System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152241Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.201629—
+2K192487EZ-TRAX Containment DeviceK1 Medical, LLC20193—
+2K190840Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20190—
+2K163600Kit Boxes and Kit PlatesNobel Biocare AB201818—
+2K163279Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20174—
+3K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC20202—
+3K193066Steripack cases and Tray SystemsAvalign Technologies, Inc.20200—
+3K181075PureSet TrayNobel Biocare AB20185—
+3K180791Straumann BLX Surgical CassetteInstitut Straumann AG201811—
+3K173615Stryker Universal Select Sterilization Tray SystemParagon Medical20182—
+4K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant…Prismatik Dentalcraft, Inc.20250—
+4K231219NobelZygoma PureSet™ TrayNobel Biocare Services AG20230—
+4K212281Surgical TraysDentsply Sirona, Inc.20225—
+4K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Nobel Biocare Services AG20212—
+4K203753Straumann Surgical CassettesStraumann USA, LLC20211—
+4K211007EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC20211—
+4K201412BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO…Bego Implant Systems GmbH & Co. KG20210—
+4K191522Straumann Modular CassetteInstitut Straumann AG20192—
+4K181845Pivot System Sterilization caseRp Medical, Inc.20190—
+4K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray…Nobel Biocare AB20194—
+4K183701Stryker ChestShield Sterilization Tray SystemParagon Medical20190—
+5K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG20260—
+5K231144WashtraysDentsply Sirona20240—
+5K233264Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr20230—
+5K223672Instrument Case P1340904Cochlear20231—
+5K220791Surgical and Prosthetic TraysDentsply Sirona20222—
+5K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceK1 Medical, LLC20210—
+6K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.20260—
+6K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.20260—
+6K231604Instrument CaseCochlear Americas20230—