DEVICE: CrossRoads™ Bone Screw (00850310006298)
Device Identifier (DI) Information
CrossRoads™ Bone Screw
Headless
In Commercial Distribution
1408-3022
CROSSROADS EXTREMITY SYSTEMS
Headless
In Commercial Distribution
1408-3022
CROSSROADS EXTREMITY SYSTEMS
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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66947 | Orthopaedic bone screw (non-sliding) |
A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.
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FDA Product Code
[?]Product Code | Product Code Name |
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HWC | Screw, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K143039 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 3.0mm x 22mm |
Device Record Status
9bc1ef53-609c-43ca-a78d-60929c4b78b0
May 30, 2025
5
May 06, 2015
May 30, 2025
5
May 06, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined