Identity
- Trade Name
- CrossRoads™ Screw FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use 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
- 7.0 Headless Implant Prep Kit Including Reamer 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
- 1456-7070 FDA UDI
- Primary DI / UDI-DI
- 00815432027514 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument handle, non-torque-limitingFluted surgical drill bit, single-useOrthopaedic intraoperative positioning pin, single-useSurgical screwdriver, single-use
CrossRoads™ Screw by Crossroads Extremity Systems Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Crossroads Extremity Systems Llc
Sources (1)
- FDA UDI d06a3a36-c185-42ad-a642-8ac50e658bb8 35 fields · synced May 30, 2026