Identity
- Trade Name
- CrossRoads™ Bone Screw FDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Device Name
- CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the bone screw. FDA UDI
- Model / Reference
- Snap-Off Screw Driver - One Piece FDA UDI
- Description
- CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the bone screw. FDA UDI
Identifiers
- Catalog Number
- 1456-2027 FDA UDI
- Primary DI / UDI-DI
- 00815432023271 FDA UDI
- 510(k) Number
- K143039 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical screwdriver, single-use 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Category: Surgical screwdriver, single-use
CrossRoads™ Bone Screw 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
K143039 also covers:
- CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
- CrossRoads™ Bone Screw — CROSSROADS EXTREMITY SYSTEMS LLC
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 22dc3e97-7f8b-48ec-8cde-bad685699f73 35 fields · synced Jun 1, 2026