OrthoNext™ Platform System Software TLHEXMODULESW1.1

GUDID 18059015375848

POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE

ORTHOFIX SRL

Radiological PACS software

• Primary Device ID: 18059015375848
• NIH Device Record Key: f3f7e882-d8f6-40b5-b856-a69fa198b15e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoNext™ Platform System Software
• Version Model Number: 1.1
• Catalog Number: TLHEXMODULESW1.1
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• 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: false
• Lot Batch: false
• 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: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18059015375848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242270

FDA Product Code

• QIH: Automated Radiological Image Processing Software

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-10
• Device Publish Date: 2025-01-31

On-Brand Devices [OrthoNext™ Platform System Software]

• 18053340345682: PREOPERATIVE JPS MODULE FOR ORTHONEXT SOFTWARE
• 18053340345675: ORTHONEXT SOFTWARE
• 18052469476451: POSTOPERATIVE MOBILE PATIENT APPLICATION SW
• 18052469476444: POSTOPERATIVE TLHEX MODULE FOR ORTHONEXT SOFTWARE
• 18052469470008: PREOPERATIVE FITBONE MODULE FOR ORTHONEXT SOFTWARE
• 18059015375848: POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE
• 18059015375831: ORTHONEXT SOFTWARE VERSION 2.1