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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, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
510(k) Number K190439
Device Name Engage™ Partial Knee System
Applicant
Engage Uni, LLC
5931 Brick Court
Suite 130
Winter Park,  FL  32792
Applicant Contact Nicholas Slater
Correspondent
Engage Surgical
3225 N. Colorado St.
Chandler,  AZ  85225
Correspondent Contact Nicholas Slater
Regulation Number888.3535
Classification Product Code
NJD  
Subsequent Product Code
HSX  
Date Received02/25/2019
Decision Date 11/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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