Balanced Knee System TriMax CR Femoral Component And E-Vitalize CR And UC Tibial Inserts

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

ORTHO DEVELOPMENT CORPORATION

The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Balanced Knee System Trimax Cr Femoral Component And E-vitalize Cr And Uc Tibial Inserts.

Pre-market Notification Details

• Device ID: K152169
• 510k Number: K152169
• Device Name: Balanced Knee System TriMax CR Femoral Component And E-Vitalize CR And UC Tibial Inserts
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: ORTHO DEVELOPMENT CORPORATION 12187 SOUTH BUSINESS PARK DRIVE Draper, UT 84020
• Contact: Drew Weaver
• Correspondent: Drew Weaver; ORTHO DEVELOPMENT CORPORATION 12187 SOUTH BUSINESS PARK DRIVE 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: 2015-08-04
• Decision Date: 2015-10-27
• Summary: summary

NIH GUDID Devices

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