CrossRoads Screw System

FDA UDI

Class II (US FDA UDI)

by Crossroads Extremity Systems Llc

Identity

Trade Name: CrossRoads Screw System FDA UDI
Generic Name: Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Device Name: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device. FDA UDI
Model / Reference: 6.5mm x 110mm Support Beam Implant & Instrument Kit FDA UDI
Description: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device. FDA UDI

Identifiers

Catalog Number: 1456-6510 FDA UDI
Primary DI / UDI-DI: 00850310006922 FDA UDI
510(k) Number: K143039 FDA UDI
K152072 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone wire

CrossRoads Screw System by Crossroads Extremity Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Crossroads Extremity Systems Llc

Sources (1)

FDA UDI 4cfaa2cb-6435-40ed-8931-930d7cea6169 37 fields · synced May 30, 2026