Identity Imprint Porous CR TCR-102-F07S

GUDID M572TCR102F07S011

IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 7 LEFT OR RIGHT

Conformis, Inc.

Cruciate-retaining total knee prosthesis

• Primary Device ID: M572TCR102F07S011
• NIH Device Record Key: ce86bfc9-a6c8-4238-be97-ee54994ecbbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identity Imprint Porous CR
• Version Model Number: TCR-102-F07S-01
• Catalog Number: TCR-102-F07S
• 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: true
• Serial Number: false
• 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

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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M572TCR102F07S011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223316

FDA Product Code

• MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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: 2023-09-18
• Device Publish Date: 2023-09-08

On-Brand Devices [Identity Imprint Porous CR ]

• M572TCR302T06S011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 6
• M572TCR302T06N011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 6N
• M572TCR302T05S011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 5
• M572TCR302T05N011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 5N
• M572TCR302T04S011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 4
• M572TCR302T04N011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 4N
• M572TCR302T03S011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 3
• M572TCR302T03N011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 3N
• M572TCR302T02S011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 2
• M572TCR302T02N011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 2N
• M572TCR302T01S011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 1
• M572TCR102F07S011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 7 LEFT OR RIGHT
• M572TCR102F06S011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 6 LEFT OR RIGHT
• M572TCR102F06N011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 6N LEFT OR RIGHT
• M572TCR102F05S011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 5 LEFT OR RIGHT
• M572TCR102F05N011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 5N LEFT OR RIGHT
• M572TCR102F04S011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 4 LEFT OR RIGHT
• M572TCR102F04N011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 4N LEFT OR RIGHT
• M572TCR102F03S011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 3 LEFT OR RIGHT
• M572TCR102F03N011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 3N LEFT OR RIGHT
• M572TCR102F02S011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 2 LEFT OR RIGHT
• M572TCR102F02N011: IDENTITY IMPRINT POROUS CR FEMORAL IMPLANT SIZE 2N LEFT OR RIGHT
• M572TCR102F01S011: POROUS CR FEMORAL IMPLANT SIZE 1 LEFT OR RIGHT
• M572POV0124411011: POROUS OVAL PATELLA, 44MM X 11MM, iPoly
• M572POV0124110011: POROUS OVAL PATELLA, 41MM X 10MM, iPoly
• M572POV0123809011: POROUS OVAL PATELLA, 38MM X 9MM, iPoly
• M572POV0123509011: POROUS OVAL PATELLA, 35MM X 9MM, iPoly
• M572POV0123208011: POROUS OVAL PATELLA, 32MM X 8MM, iPoly
• M572TCR302T07S011: IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 7