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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K182301
Device Name PFC SIGMA Knee System
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw,  IN  46582
Applicant Contact Kathy Harris
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw,  IN  46582
Correspondent Contact Brian Kincaid
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received08/24/2018
Decision Date 11/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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