iTotal Identity CR Knee Replacement System (with CS Insert) RCR-013-100E

GUDID M572RCR013100E011

ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 10MM, LEFT OR RIGHT

Conformis, Inc.

Tibial insert

• Primary Device ID: M572RCR013100E011
• NIH Device Record Key: 2fda13ff-1c2f-45fd-aee2-e57288ec2ad4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal Identity CR Knee Replacement System (with CS Insert)
• Version Model Number: RCR013100E01
• Catalog Number: RCR-013-100E
• 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: false
• 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
• 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 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	M572RCR013100E011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210809

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-01
• Device Publish Date: 2021-05-24

On-Brand Devices [iTotal Identity CR Knee Replacement System (with CS Insert)]

• M572TCR023140J011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 14MM, LEFT OR RIGHT
• M572TCR023130H011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 13MM, LEFT OR RIGHT
• M572TCR023120G011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 12MM, LEFT OR RIGHT
• M572TCR023110F011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 11MM, LEFT OR RIGHT
• M572TCR023100E011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 10MM, LEFT OR RIGHT
• M572TCR023090D011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 9MM, LEFT OR RIGHT
• M572TCR023080C011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 8MM, LEFT OR RIGHT
• M572TCR023070B011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 7MM, LEFT OR RIGHT
• M572TCR023060A011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, CS, SINGLE, 6MM, LEFT OR RIGHT
• M572TCR013140J011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 14MM, LEFT OR RIGHT
• M572TCR013130H011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 13MM, LEFT OR RIGHT
• M572TCR013120G011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 12MM, LEFT OR RIGHT
• M572TCR013110F011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 11MM, LEFT OR RIGHT
• M572TCR013100E011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 10MM, LEFT OR LEFT
• M572TCR013090D011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 9MM, LEFT OR RIGHT
• M572TCR013080C011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 8MM, LEFT OR RIGHT
• M572TCR013070B011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 7MM, LEFT OR RIGHT
• M572TCR013060A011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, CS, SINGLE, 6MM, LEFT or RIGHT
• M572RCR023080C011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 8MM, LEFT OR RIGHT
• M572RCR023070B011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 7MM, LEFT OR RIGHT
• M572RCR023060A011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 6MM, LEFT OR RIGHT
• M572RCR013200R011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 20MM, LEFT OR RIGHT
• M572RCR013190P011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 19MM, LEFT OR RIGHT
• M572RCR013180N011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 18MM, LEFT OR RIGHT
• M572RCR013170M011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 17MM, LEFT OR RIGHT
• M572RCR013160L011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 16MM, LEFT OR RIGHT
• M572RCR013150K011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 15MM, LEFT OR RIGHT
• M572RCR013140J011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 14MM, LEFT OR RIGHT
• M572RCR013130H011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 13MM, LEFT OR RIGHT
• M572RCR013120G011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 12MM, LEFT OR RIGHT
• M572RCR013110F011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 11MM, LEFT OR RIGHT
• M572RCR013100E011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 10MM, LEFT OR RIGHT
• M572RCR013090D011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 9MM, LEFT OR RIGHT
• M572RCR013080C011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 8MM, LEFT OR RIGHT
• M572RCR013070B011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 7MM, LEFT OR RIGHT
• M572RCR013060A011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, CS, SINGLE, 6MM, LEFT OR RIGHT
• M572RCR023200R011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 20MM, LEFT OR RIGHT
• M572RCR023190P011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 19MM, LEFT OR RIGHT
• M572RCR023180N011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 18MM, LEFT OR RIGHT
• M572RCR023170M011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 17MM, LEFT OR RIGHT
• M572RCR023160L011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 16MM, LEFT OR RIGHT
• M572RCR023150K011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 15MM, LEFT OR RIGHT
• M572RCR023140J011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 14MM, LEFT OR RIGHT
• M572RCR023130H011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 13MM, LEFT OR RIGHT
• M572RCR023120G011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 12MM, LEFT OR RIGHT
• M572RCR023110F011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 11MM, LEFT OR RIGHT
• M572RCR023100E011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 10MM, LEFT OR RIGHT
• M572RCR023090D011: ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, CS, SINGLE, 9MM, LEFT OR RIGHT
• M572RCR013160L111: ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, CS, SINGLE, 16MM, LEFT OR RIGHT
• M572RCR013150K111: ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, CS, SINGLE, 15MM, LEFT OR RIGHT