Portal KNP001

GUDID 03760297030148

Software for Total Knee Arthroplasty

PIXEE MEDICAL

Orthopaedic stereotactic surgery system

• Primary Device ID: 03760297030148
• NIH Device Record Key: 69073108-10dc-4875-b65e-05cd6c0cf5fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portal
• Version Model Number: Knee+
• Catalog Number: KNP001
• Company DUNS: 270195749
• Company Name: PIXEE MEDICAL
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760297030148 [Primary]

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

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: 2022-10-12
• Device Publish Date: 2022-10-04

Devices Manufactured by PIXEE MEDICAL

• 03760297030438 - Orientation and resection mechanism: 2025-04-28 Reusable instrument for Total Knee Arthroplasty
• 03760297030445 - Adjustable cutting guide adaptor: 2025-04-28 Reusable instrument for Total Knee Arthroplasty
• 03760297030452 - KneeTools Instrument Box V6: 2025-04-28 Storage box for orthopedic surgical instruments
• 03760297030469 - KneePlus: 2025-04-28 Software for Total Knee Arthroplasty
• 03760297030483 - Kit KneeTools V6: 2025-04-28 Kit of reusable instruments for Total Knee Arthroplasty
• 03760297030285 - Modular Pointer: 2025-04-21 Reusable instrument for Total Knee Arthroplasty
• 03760297030223 - SHA Outer ring: 2023-06-26
• 03760297030247 - SHA Connector: 2023-06-26