-7mm First Cut Adaptor

GUDID 05065012584394

Allows for an initial 7mm resection of the patella

EVENTUM ORTHOPAEDICS LTD

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 05065012584394
• NIH Device Record Key: 9b27968e-b095-453c-bda0-c030cebe9c33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: -7mm First Cut Adaptor
• Version Model Number: GG017
• Company DUNS: 226230358
• Company Name: EVENTUM ORTHOPAEDICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05065012584394 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[05065012584394]

Moist Heat or Steam Sterilization

[05065012584394]

Moist Heat or Steam Sterilization

[05065012584394]

Moist Heat or Steam Sterilization

[05065012584394]

Moist Heat or Steam Sterilization

[05065012584394]

Moist Heat or Steam Sterilization

[05065012584394]

Moist Heat or Steam Sterilization

[05065012584394]

Moist Heat or Steam Sterilization

[05065012584394]

Moist Heat or Steam Sterilization

[05065012584394]

Moist Heat or Steam Sterilization

[05065012584394]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-27
• Device Publish Date: 2025-02-19

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