Identity Imprint CR Knee Replacement System TCR-000-D00T

GUDID M572TCR000D00T021

CR TIBIAL INSTRUMENTS ALL SIZES LEFT OR RIGHT

Conformis, Inc.

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• Primary Device ID: M572TCR000D00T021
• NIH Device Record Key: fc0326f4-9db8-4924-90f4-9c9f75e916eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identity Imprint CR Knee Replacement System
• Version Model Number: TCR-000-D00T1
• Catalog Number: TCR-000-D00T
• 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

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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M572TCR000D00T021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210191

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: 2024-07-04
• Device Publish Date: 2024-06-26

On-Brand Devices [Identity Imprint CR Knee Replacement System]

• M572TCR000D00T021: CR TIBIAL INSTRUMENTS ALL SIZES LEFT OR RIGHT
• M572TCR000D00F021: CR FEMORAL INSTRUMENTS,ALL SIZES LEFT AND RIGHT