Apollo Knee

GUDID 05056139244919

BalanceBot Tibial Tray, Size Small Right

CORIN LTD

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 05056139244919
• NIH Device Record Key: f4ff591c-4fb5-4782-b596-0a8d795657c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo Knee
• Version Model Number: TKR.BB.1400
• Company DUNS: 295437313
• Company Name: CORIN 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: 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: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com
• Phone: +4401285649231
• Email: customersupport@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056139244919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231172

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

[05056139244919]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-26
• Device Publish Date: 2024-12-18

On-Brand Devices [Apollo Knee]

• 05056139246791: Apollo BalanceBot Cable
• 05056139246784: Apollo Robot Cable
• 05056139246036: Station Power Cable
• 05056139246029: Camera Assembly ST
• 05056139246012: Camera Assembly VT
• 05056139246005: Apollo Station (EU)
• 05056139245862: ApolloKnee Software
• 05056139245831: Apollo Station (US)
• 05056139245824: BalanceBot
• 05056139245763: Apollo Robot Enclosure Lid
• 05056139245756: Apollo Robot Enclosure Body
• 05056139245855: Tibial Cutting Guide Rail
• 05056139245749: V-Array
• 05056139245732: Tibial Cutting Guide - Right
• 05056139245725: Tibial Cutting Guide - Left
• 05056139245701: Femoral Sawing Guide
• 05056139245169: P-Array
• 05056139245152: G-Array
• 05056139244964: F-Array
• 05056139244957: T-Array
• 05056139244919: BalanceBot Tibial Tray, Size Small Right