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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 K183017
Device Name Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer
Applicant
Osteoremedies, LLC
6800 Poplar Ave.
Suite 120
Memphis,  TN  38138
Applicant Contact Chris Hughes
Correspondent
Mandell Horwitz Consultants, LLC
2995 Steven Martin Dr.
Fairfax,  VA  20031
Correspondent Contact Diane Mandell Horwitz
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/31/2018
Decision Date 07/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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