iDuo® Tibial Kit RBK1011113

GUDID M572RBK1011113021

IDUO–TIBIAL TRAY KIT–LEFT or right MEDIAL or lateral

Conformis, Inc.

Bicompartmental knee prosthesis Bicompartmental knee prosthesis Bicompartmental knee prosthesis Bicompartmental knee prosthesis Bicompartmental knee prosthesis Bicompartmental knee prosthesis Bicompartmental knee prosthesis Bicompartmental knee prosthesis Bicompartmental knee prosthesis

• Primary Device ID: M572RBK1011113021
• NIH Device Record Key: 92d707d2-1c49-4297-8630-d9150bef055a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iDuo® Tibial Kit
• Version Model Number: RBK101111302
• Catalog Number: RBK1011113
• Company DUNS: 808821883
• Company Name: Conformis, Inc.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572RBK1011113021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093513

FDA Product Code

• NPJ: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-08-15
• Device Publish Date: 2015-10-26

On-Brand Devices [iDuo® Tibial Kit]

• M572RBK1011113021: IDUO–TIBIAL TRAY KIT–LEFT or right MEDIAL or lateral
• M572RBK1011113011: N/A