iDuo® iPoly™ Insert Kit RBK0101000

GUDID M572RBK0101000021

IDUO IPOLY 11MM INSERT KIT LEFT or right MEDIAL or lateral

Conformis, Inc.

Unicondylar knee insert

• Primary Device ID: M572RBK0101000021
• NIH Device Record Key: d5e35ac5-a8f1-4db4-af68-9be707dcf40f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iDuo® iPoly™ Insert Kit
• Version Model Number: RBK010100002
• Catalog Number: RBK0101000
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M572RBK0101000021 [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® iPoly™ Insert Kit]

• M572RBK0100700011: N/A
• M572RBK0101300021: N/A
• M572RBK0101100021: IDUO IPOLY 11MM INSERT KIT LEFT or right MEDIAL or lateral
• M572RBK0101000021: IDUO IPOLY 11MM INSERT KIT LEFT or right MEDIAL or lateral
• M572RBK0100700021: IDUO–IPOLY–7MM INSERT KIT–LEFT or right MEDIAL or lateral
• M572RBK0101200011: N/A
• M572RBK0101100011: N/A
• M572RBK0100900011: N/A
• M572RBK0100600011: N/A