iTotal® CR iPoly XE™ Insert Kit RCR020000H

GUDID M572RCR020000H011

N/A

Conformis, Inc.

Total knee prosthesis implantation guide-instrument kit

• Primary Device ID: M572RCR020000H011
• NIH Device Record Key: b3a446fc-f048-427d-867e-2fb6d935d327
• Commercial Distribution Discontinuation: 2022-08-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: iTotal® CR iPoly XE™ Insert Kit
• Version Model Number: RCR020000H01
• Catalog Number: RCR020000H
• Company DUNS: 808821883
• Company Name: Conformis, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572RCR020000H011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140423

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, 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: 2022-08-16
• Device Publish Date: 2015-10-26

On-Brand Devices [iTotal® CR iPoly XE™ Insert Kit]

• M572RCR0201600011: N/A
• M572RCR0201500011: N/A
• M572RCR0201400011: N/A
• M572RCR0201300011: N/A
• M572RCR0201200011: N/A
• M572RCR0201100011: N/A
• M572RCR0201000011: N/A
• M572RCR0200900011: N/A
• M572RCR0200800011: N/A
• M572RCR0200700011: N/A
• M572RCR0200600011: N/A
• M572RCR020000K011: N/A
• M572RCR020000J011: N/A
• M572RCR020000I011: N/A
• M572RCR020000H011: N/A
• M572RCR020000G011: N/A
• M572RCR020000F011: N/A
• M572RCR020000E011: N/A
• M572RCR020000D011: N/A
• M572RCR020000C011: N/A
• M572RCR020000B011: N/A
• M572RCR020000A011: N/A