FDA.report

510(k) K241050

Device
CrossRoads Modular Tray System
Applicant
Crossroads Extremity Systems
510(k) number
K241050
Product code
KCT
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-16
Date received
2024-04-17
Regulation
880.6850
Classification name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jacqueline Gorberg
Address
6423 Shelby View Dr. Suite 101 Memphis TN US 38134 38134

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00810112599749PRO-SPECCROSSROADS EXTREMITY SYSTEMS2025-03-13
00810112598735CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-08-01
00810112598582CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-08-01
00810112598339CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-08-01
00810112598322CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-08-01
00810112598254CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-08-01
00810112598179CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-08-01
00810112598124CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-08-01
00810112598087CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-08-01
00810112597899CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-08-01
00810112597547CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-08-01
00810112598223CrossRoads Modular Tray SystemCROSSROADS EXTREMITY SYSTEMS2024-07-31

Other 510(k) Records For Product Code KCT

510(k)DeviceApplicantDecision date
K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.2026-02-26
K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.2026-02-06
K251756Sterilization TraysParagon Implant Mfg., LLC2025-11-14
K251300Plastic Surgical KitsDentsply Sirona, Inc.2025-07-22
K243425Guided DAS Surgical KitTalladium España, SL2025-07-22
K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLC2025-06-20
K242762Aesculap Aicon® Series Container SystemAesculap, Inc.2025-05-13
K250029ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies2025-05-01
K241927Synthes Graphic Case & Tray SystemSynthes GmbH2025-03-28
K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)Prismatik Dentalcraft, Inc.2025-03-21
K242023Microdent Sterilization CassetteImplant Microdent System S.L.U.2025-02-19
K243317NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd.2025-02-11
K242834System 9 Sterile Battery ContainerStryker Instruments2025-01-16
K243128Klockner KitsSOADCO, S.L.2024-12-18
K241492Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.2024-08-23