FDA.report

CrossRoads Modular Tray System

Primary DI
00810112598339
Brand
CrossRoads Modular Tray System
Company
CROSSROADS EXTREMITY SYSTEMS
Model
CROSSROADS 2/3 LID
Catalog number
28062LPKG
Device description
CROSSROADS 2/3 LID
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K241050000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241050000CrossRoads Modular Tray SystemCrossroads Extremity Systems2024-07-16KCT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810112598339PrimaryGS10

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
058864308
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810112596793TriLeap Lower Extremity Anatomic Plating System04.900.151049001512026-02-19
00810112597202TriLeap Lower Extremity Anatomic Plating System04.913.035049130352026-02-19
00810112597219TriLeap Lower Extremity Anatomic Plating System04.913.040049130402026-02-19
00810112597226TriLeap Lower Extremity Anatomic Plating System04.913.045049130452026-02-19
00810112597233TriLeap Lower Extremity Anatomic Plating System04.913.050049130502026-02-19
00810112597240TriLeap Lower Extremity Anatomic Plating System04.913.055049130552026-02-19
00810112597257TriLeap Lower Extremity Anatomic Plating System04.913.060049130602026-02-19
00810112597264TriLeap Lower Extremity Anatomic Plating System04.913.065049130652026-02-19
00810112597271TriLeap Lower Extremity Anatomic Plating System04.914.035049140352026-02-19
00810112597288TriLeap Lower Extremity Anatomic Plating System04.914.040049140402026-02-19
00810112597295TriLeap Lower Extremity Anatomic Plating System04.914.050049140502026-02-19
00810112597301TriLeap Lower Extremity Anatomic Plating System04.914.045049140452026-02-19
00810112597318TriLeap Lower Extremity Anatomic Plating System04.914.055049140552026-02-19
00810112597325TriLeap Lower Extremity Anatomic Plating System04.914.060049140602026-02-19
00810112597332TriLeap Lower Extremity Anatomic Plating System04.914.065049140652026-02-19
00810112598933TriLeap Lower Extremity Anatomic Plating System04.900.118049001182026-02-19
00810112598940TriLeap Lower Extremity Anatomic Plating System04.900.119049001192026-02-19
00810112598957TriLeap Lower Extremity Anatomic Plating System04.900.120049001202026-02-19
00810112598964TriLeap Lower Extremity Anatomic Plating System04.900.121049001212026-02-19
00810112598971TriLeap Lower Extremity Anatomic Plating System04.900.122049001222026-02-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00385640091183INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091190INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091206INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091152INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00385640091169INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00385640091176INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00199150051212Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-22
00763000710194Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-22
00199150015429CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00199150015436CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869069CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869076CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869090CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869106CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869892CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869908CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869915CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869922CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869939CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00385640091114INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091121INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091138INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091145INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00653159013232CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159013256CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159014062CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159014086CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159014123CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159014727CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159014734CASE MEDICALCase Medical Inc.KCT2026-03-20