iDuo® Patella PAB0113508

GUDID M572PAB0113508021

Conformis, Inc.

Polyethylene patella prosthesis

• Primary Device ID: M572PAB0113508021
• NIH Device Record Key: 6c5ba64e-50c1-4eba-a1d3-d6a5c57bf729
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iDuo® Patella
• Version Model Number: PAB011350802
• Catalog Number: PAB0113508
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572PAB0113508021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093513

FDA Product Code

• NPJ: Prosthesis, Knee Patellofemorotibial, Partial, 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: 2019-10-07
• Device Publish Date: 2019-09-27

On-Brand Devices [iDuo® Patella]

• M572PAB0113508021: PAB011350802
• M572PAB0113207021: PAB011320702
• M572PAB0114110021: N/A
• M572PAB0113808021: N/A
• M572PAB0113507021: N/A
• M572PAB0113206021: N/A