BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Balanced Knee System Modular Revision Knee System.

Pre-market Notification Details

• Device ID: K060569
• 510k Number: K060569
• Device Name: BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020
• Contact: William J Griffin
• Correspondent: William J Griffin; ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-03
• Decision Date: 2006-07-06

NIH GUDID Devices

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