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CrossRoads Screw System
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K152072
Identity
- Trade Name
- CrossRoads Screw System FDA UDI
- Generic Name
- Orthopaedic bone wire 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 105mm 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
- 1456-6505 FDA UDI
- Primary DI / UDI-DI
- 00850310006915 FDA UDI
- FDA Product Code
- HWC FDA 510(k)FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)FDA UDI
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CrossRoads Screw System by Crossroads Extremity Systems, LLC — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152072 | Class II | Active |
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Manufacturer
- Manufacturer
- Crossroads Extremity Systems, LLC
Sources (2)
- FDA 510(k) K152072 24 fields · synced Jun 18, 2026
- FDA UDI 960e52c7-bcf8-4049-9217-9e1165a7aee4 37 fields · synced May 27, 2026