DyanBunion 7108-DSHL

GUDID 00850038154424

The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452.

CROSSROADS EXTREMITY SYSTEMS

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00850038154424
• NIH Device Record Key: bf7300d6-97d8-40ea-8b54-0fe86bb9951b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DyanBunion
• Version Model Number: DynaBunion Plate SHORT 18mm - LEFT
• Catalog Number: 7108-DSHL
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850038154424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223342

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-11
• Device Publish Date: 2023-08-03

On-Brand Devices [DyanBunion]

• 00850038154448: The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and D
• 00850038154431: The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and D
• 00850038154424: The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and D
• 00850038154417: The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and D