Quadsense

GUDID 05065012584158

Single use sensor

EVENTUM ORTHOPAEDICS LTD

Arthroplasty force sensor

• Primary Device ID: 05065012584158
• NIH Device Record Key: bec7d621-96a6-4930-9d94-c35033a88ab4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quadsense
• Version Model Number: SE001
• Company DUNS: 226230358
• Company Name: EVENTUM ORTHOPAEDICS LTD
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com
• Phone: +442045428754
• Email: regulatory@eventumortho.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05065012584158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241298

FDA Product Code

• ONN: Intraoperative Orthopedic Joint Assessment Aid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-30
• Device Publish Date: 2025-01-22

Devices Manufactured by EVENTUM ORTHOPAEDICS LTD

• 05065012584493 - Quadsense Pro: 2025-04-14 Single Use Sensor
• 05065012584189 - Reusable 6mm shim: 2025-02-27 6mm spacer for patella assessment.
• 05065012584196 - Reusable 7mm shim: 2025-02-27 7mm spacer for patella assessment.
• 05065012584202 - Reusable 6mm 2.5 degree shim: 2025-02-27 6mm 2.5 degree spacer for patella assessment.
• 05065012584219 - Reusable 7mm 2.5 degree shim: 2025-02-27 7mm 2.5 degree spacer for patella assessment.
• 05065012584226 - Extraction Tool: 2025-02-27 Tool for dismantling patella spacers
• 05065012584332 - -1mm Cutting Guide Depth Adaptor: 2025-02-27 Allows for a 1mm adjustment resection of the patella
• 05065012584349 - -2mm Cutting Guide Depth Adaptor: 2025-02-27 Allows for a 2mm adjustment resection of the patella