FX Shoulder Positioning System

GUDID 03760297030209

Planning software for total shoulder arthroplasty

PIXEE MEDICAL

Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software

• Primary Device ID: 03760297030209
• NIH Device Record Key: 57a1ca4b-49a4-4380-8e00-bddab577f814
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX Shoulder Positioning System
• Version Model Number: FXSPS001
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760297030209 [Primary]

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: 2022-10-24
• Device Publish Date: 2022-10-14

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: 2022-10-24Planning software for total shoulder 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: 2022-10-12 Software for Total Knee Arthroplasty
• 03760297030155 - Slim Bone Reference: 2022-10-12 Reusable instrument for Total Knee Arthroplasty