iTotal® CR iPoly® XE Insert Kit RCR0201600

GUDID M572RCR0201600131

ITOTAL CR IPOLY XE 16MM MEDIAL INSERT KIT LEFT or right NO TRIAL

Conformis, Inc.

Tibial insert

• Primary Device ID: M572RCR0201600131
• NIH Device Record Key: 9d312e67-3789-48ba-b9f2-00b45d84d900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal® CR iPoly® XE Insert Kit
• Version Model Number: RCR020160013
• Catalog Number: RCR0201600
• 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

Device Dimensions

• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572RCR0201600131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153721

FDA Product Code

• OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-08-15
• Device Publish Date: 2018-04-27

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

• M572RCR0201600131: ITOTAL CR IPOLY XE 16MM MEDIAL INSERT KIT LEFT or right NO TRIAL
• M572RCR0201500131: ITOTAL CR IPOLY XE 15MM MEDIAL INSERT KIT LEFT or right NO TRIAL
• M572RCR0201400131: ITOTAL CR IPOLY XE 14MM MEDIAL INSERT KIT RIGHT NO TRIAL
• M572RCR0201300131: ITOTAL CR IPOLY XE 13MM MEDIAL INSERT KIT LEFT or right NO TRIAL
• M572RCR0201200131: ITOTAL CR IPOLY XE 12MM MEDIAL INSERT KIT left or RIGHT NO TRIAL
• M572RCR0201100131: ITOTAL CR IPOLY XE 11MM MEDIAL INSERT KIT LEFT or right NO TRIAL
• M572RCR0201000131: ITOTAL CR IPOLY XE 10MM MEDIAL INSERT KIT LEFT or right NO TRIAL
• M572RCR0200900131: ITOTAL CR IPOLY XE 9MM MEDIAL INSERT KIT LEFT or right NO TRIAL
• M572RCR0200800131: ITOTAL CR IPOLY XE 8MM MEDIAL INSERT KIT LEFT or right NO TRIAL
• M572RCR0200600131: ITOTAL CR IPOLY XE 6MM MEDIAL INSERT KIT LEFT or right NO TRIAL
• M572RCR020000K131: ITOTAL CR IPOLY XE LATERAL K INSERT KIT LEFT or right NO TRIAL
• M572RCR020000I131: ITOTAL CR IPOLY XE LATERAL I INSERT KIT LEFT or right NO TRIAL
• M572RCR020000G131: ITOTAL CR IPOLY XE LATERAL G INSERT KIT LEFT or right NO TRIAL
• M572RCR020000F131: ITOTAL CR IPOLY XE LATERAL F INSERT KIT LEFT or right NO TRIAL
• M572RCR020000E131: ITOTAL CR IPOLY XE LATERAL E INSERT KIT LEFT NO TRIAL
• M572RCR020000D131: ITOTAL CR IPOLY XE LATERAL D INSERT KIT LEFT NO TRIAL
• M572RCR020000B131: ITOTAL CR IPOLY XE LATERAL B INSERT KIT LEFT or right NO TRIAL
• M572RCR020000A131: ITOTAL CR IPOLY XE LATERAL A INSERT KIT LEFT NO TRIAL
• M572RCR020000H131: N/A
• M572RCR020000J131: ITOTAL CR IPOLY XE LATERAL J INSERT KIT LEFT or right NO TRIAL