iTotal® Patella Trial

GUDID 00850268007095

iTotal® 32mm Patella Trial Reusable Instrument

Conformis, Inc.

Patella prosthesis trial

• Primary Device ID: 00850268007095
• NIH Device Record Key: 978fa045-b281-47b7-8578-8025deb11ef7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal® Patella Trial
• Version Model Number: 1080-510
• 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

Device Dimensions

• Outer Diameter: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850268007095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160025

FDA Product Code

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

Sterilization

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

[00850268007095]

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

On-Brand Devices [iTotal® Patella Trial]

• 00850268007125: iTotal® 41mm Patella Trial Reusable Instrument
• 00850268007118: iTotal® 38mm Patella Trial Reusable Instrument
• 00850268007101: iTotal® 35mm Patella Trial Reusable Instrument
• 00850268007095: iTotal® 32mm Patella Trial Reusable Instrument
• 00850268007088: iTotal® 29mm Patella Trial Reusable Instrument