iDuo® Patella Trial

GUDID 00850268007378

iDuo® 35mm Patella Trial Reusable Instrument

Conformis, Inc.

Patella prosthesis trial

• Primary Device ID: 00850268007378
• NIH Device Record Key: 135981f5-61f2-4b1a-8d2a-f4037c65bc49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iDuo® Patella Trial
• Version Model Number: 1080-403
• 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: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850268007378 [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

[00850268007378]

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 [iDuo® Patella Trial ]

• 00850268007392: iDuo® 41mm Patella Trial Reusable Instrument
• 00850268007385: iDuo® 38mm Patella Trial Reusable Instrument
• 00850268007378: iDuo® 35mm Patella Trial Reusable Instrument
• 00850268007361: iDuo® 32mm Patella Trial Reusable Instrument