OrthoNext™ Platform System Software ORTHONEXTSW

GUDID 18053340345675

ORTHONEXT SOFTWARE

ORTHOFIX SRL

Radiology PACS software

• Primary Device ID: 18053340345675
• NIH Device Record Key: 179b762d-5851-4ba7-a4ef-1f69e714abed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoNext™ Platform System Software
• Version Model Number: 2.0
• Catalog Number: ORTHONEXTSW
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053340345675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202519

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-04-10
• Device Publish Date: 2023-03-31

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