Identity
- Trade Name
- CrossRoads™ 3.5mm x 46mm Anti-Drift Bolt FDA UDI
- Generic Name
- Surgical depth gauge, 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
- 15LP-3546 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
- 15LP-3546 FDA UDI
- Primary DI / UDI-DI
- 00815432028887 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDIJDR FDA UDI
- GMDN Term
- Surgical depth gauge, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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
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 instrument handle, non-torque-limitingFluted surgical drill bit, single-useOrthopaedic intraoperative positioning pin, single-useSurgical screwdriver, single-use
CrossRoads™ 3.5mm x 46mm Anti-Drift Bolt by Crossroads Extremity Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical depth gauge, single-use.
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- General Instrument — ALPHATEC SPINE, INC. · Class I
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- Solanas — ALPHATEC SPINE, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- DVR® CROSSLOCK EPAK™DEPTH GAUGE — Biomet Orthopedics, Inc. · Class I
- FuzeFix Mini — FUSION ORTHOPEDICS, LLC · Class I
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class I
Cleared under the same submission
K193452 also covers:
- HiMAX C — CROSSROADS EXTREMITY SYSTEMS LLC
- HiMAX C — CROSSROADS EXTREMITY SYSTEMS LLC
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- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND CP — CROSSROADS EXTREMITY SYSTEMS LLC
K223342 also covers:
- DynaFORCE Staple Instruments — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — 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 006e8437-1ead-4b05-9244-c3b61b41be5a 36 fields · synced May 30, 2026