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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 K181569
Device Name BKS Revision Sleeves System
Applicant
Ortho Development Corporation
12187 So. Business Park Drive
Draper,  UT  84020
Applicant Contact Dan Petersen
Correspondent
Ortho Development Corporation
12187 So. Business Park Drive
Draper,  UT  84020
Correspondent Contact Dan Petersen
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received06/14/2018
Decision Date 10/12/2018
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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