THE NUFFIELD TOTAL KNEE SYSTEM

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

CORIN U.S.A.

The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for The Nuffield Total Knee System.

Pre-market Notification Details

• Device ID: K980545
• 510k Number: K980545
• Device Name: THE NUFFIELD TOTAL KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612
• Contact: Craig Corrance
• Correspondent: Craig Corrance; CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-02-12
• Decision Date: 1998-04-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05055196910607	K980545	000
05055196945913	K980545	000
05055196945920	K980545	000
05055196945937	K980545	000
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