DynaBunion 7108-DSTR

GUDID 00850038154486

DynaBunion Plate STD 18mm Right

CROSSROADS EXTREMITY SYSTEMS

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00850038154486
• NIH Device Record Key: 3f756fcc-d8a1-4423-ae89-f75972645cda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaBunion
• Version Model Number: DynaBunion Plate STD 18mm Right
• Catalog Number: 7108-DSTR
• 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	00850038154486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223342

FDA Product Code

• HWC: Screw, 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: 2024-05-09
• Device Publish Date: 2024-05-01

On-Brand Devices [DynaBunion ]

• 00850038154226: 1500-48FH
• 00850038154189: The MotoBAND™ CP DynaForce® MPJ Implant System is a bone plating system indicated for stabili
• 00850038154646: DynaBunion IMA Reducer - Disposable Sterile
• 00850038154486: DynaBunion Plate STD 18mm Right
• 00850038154462: DynaBunion Plate STD 18mm - Left Sterile
• 00850038154479: DynaBuion Plate STD 15mm - Right Sterile
• 00850038154455: DynaBunion Plate STD 15mm - Left Sterile
• 00810112598247: DynaBunion RACBlock, Size 2
• 00810112598230: DynaBunion RACBlock, Size 1
• 00810112598193: DynaBunion RAC Block, Size 0
• 00810112598285: Compressor Block, Size 3