Portal KNP001

GUDID 03760297030148

Software for Total Knee Arthroplasty

PIXEE MEDICAL

Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system 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

• 03760297030223 - SHA Outer ring: 2023-06-26
• 03760297030247 - SHA Connector: 2023-06-26
• 03760297030315 - KneePlus: 2023-06-26 Software for Total Knee Arthroplasty
• 03760297030209 - FX Shoulder Positioning System: 2022-10-24 Planning software for total shoulder arthroplasty
• 03760297030124 - KneePlus: 2022-10-12 Software for Total Knee Arthroplasty
• 03760297030131 - Long Pointer: 2022-10-12 Reusable instrument for Total Knee Arthroplasty
• 03760297030148 - Portal: 2022-10-12Software for Total Knee Arthroplasty
• 03760297030148 - Portal: 2022-10-12 Software for Total Knee Arthroplasty
• 03760297030155 - Slim Bone Reference: 2022-10-12 Reusable instrument for Total Knee Arthroplasty