CrossRoads Screw System 1456-6500

GUDID 00850310006908

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.

CROSSROADS EXTREMITY SYSTEMS

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00850310006908
• NIH Device Record Key: 28e02b33-cd64-49c9-ab98-9cd6d37d860d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CrossRoads Screw System
• Version Model Number: 6.5mm x 100mm Support Beam Implant & Instrument Ki
• Catalog Number: 1456-6500
• Company DUNS: 058864308
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850310006908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143039

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-07

On-Brand Devices [CrossRoads Screw System]

• 00850310006946: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusi
• 00850310006939: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusi
• 00850310006922: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusi
• 00850310006915: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusi
• 00850310006908: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusi
• 00850310006892: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusi
• 00850310006885: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusi
• 00850310006878: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusi
• 00850310006861: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusi
• 00850310006854: The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusi