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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal
510(k) Number K173967
Device Name Remedy Acetabular Cup
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 Number888.3360
Classification Product Code
KWL  
Subsequent Product Codes
KWY   KWZ  
Date Received12/29/2017
Decision Date 02/22/2018
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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