Identity
- Trade Name
- CrossRoads™ Bone Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) 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
- Headed 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
- 1406-3026 FDA UDI
- Primary DI / UDI-DI
- 00850310006212 FDA UDI
- 510(k) Number
- K143039 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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
Yes
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: Orthopaedic bone screw (non-sliding)
CrossRoads™ Bone Screw by Crossroads Extremity Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
- ARIX System Bone Screw — Jeil Medical Corporation · Class II
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 113869e7-bfb6-4979-830b-f737d018303e 36 fields · synced May 30, 2026