iDuo® Patella Implant Sizer

GUDID 00850268007408

iDuo® 32mm Patella Sizer Reusable Instrument

Conformis, Inc.

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• Primary Device ID: 00850268007408
• NIH Device Record Key: 562b4979-59fa-4dd4-9b36-bf7259d7e292
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iDuo® Patella Implant Sizer
• Version Model Number: 1080-407
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Dimensions

• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850268007408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133256

FDA Product Code

• NPJ: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

[00850268007408]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-24

Devices Manufactured by Conformis, Inc.

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• M572TCR000D00T021 - Identity Imprint CR Knee Replacement System: 2024-07-04 CR TIBIAL INSTRUMENTS ALL SIZES LEFT OR RIGHT
• M572TPS000D00F021 - Identity Imprint PS Knee Replacement System: 2024-07-04 PS Femoral INSTRUMENTS,ALL SIZES LEFT AND RIGHT
• M572TCR302T07S011 - Identity Imprint Porous CR: 2024-02-01 IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 7
• 00810933031817 - Calcar Planer Adapter Drop-in: 2023-12-13 Calcar Planer Adapter Drop-in ED-09733
• M572POV0123208011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 32MM X 8MM, iPoly
• M572POV0123509011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 35MM X 9MM, iPoly
• M572POV0123809011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 38MM X 9MM, iPoly