Caliber Intramedullary Fixation System

GUDID 00810135963039

5.0mm implant 120mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fixation screw system used to repair an acute fracture, mal-union or non-union of the clavicle. The intramedullary implant consists of a cannulated screw with distal and proximal threads, a cross-screw receiving hole and a screw head. The diameter ranges from 4.5mm to 5.0mm in lengths from 50mm to 120mm.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Clavicle intramedullary nail-like rod

• Primary Device ID: 00810135963039
• NIH Device Record Key: 4f46a088-440e-4f3f-a0af-f09ba7f95e4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caliber Intramedullary Fixation System
• Version Model Number: CLN-50-120
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: Denisealva@nvisionbiomed.com

Device Dimensions

• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 120 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810135963039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242896

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

[00810135963039]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-29
• Device Publish Date: 2025-07-21

On-Brand Devices [Caliber Intramedullary Fixation System]

• 00810135963114: Caliber Intramedullary Fixation System Tray Assembly. The Caliber Intramedullary Fixation Syste
• 00810135963107: Caliber Kwire Guide The Caliber Intramedullary Fixation System is an intramedullary bone fixatio
• 00810135963091: Caliber Depth Gauge The Caliber Intramedullary Fixation System is an intramedullary bone fixatio
• 00810135963084: Caliber Drill for 5.0 Implant The Caliber Intramedullary Fixation System is an intramedullary b
• 00810135963077: Caliber Drill for 4.5 Implant The Caliber Intramedullary Fixation System is an intramedullary b
• 00810135963060: Caliber Hex Drive Inserter The Caliber Intramedullary Fixation System is an intramedullary bone
• 00810135963053: Caliber Inserter T15 Hexalobe The Caliber Intramedullary Fixation System is an intramedullary bo
• 00810135963046: Caliber Multidrive Inserter The Caliber Intramedullary Fixation System is an intramedullary bone
• 00810135963039: 5.0mm implant 120mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
• 00810135963022: 5.0mm implant 110mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
• 00810135963015: 5.0mm implant 100mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
• 00810135963008: 5.0mm implant 90mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fi
• 00810135962995: 5.0mm implant 80mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fi
• 00810135962988: 4.5mm implant 120mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
• 00810135962971: 4.5mm implant 110mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
• 00810135962964: 4.5mm implant 100mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
• 00810135962957: 4.5mm implant 90mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fi
• 00810135962940: 4.5mm implant 80mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fi
• 00810005668040: Double Trocar 1.4mm kwire