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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 K191981
Device Name REMEDY Acetabular Cup
Applicant
Osteoremedies, LLC
6800 Poplar Ave.
#120
Germantown,  TN  38138
Applicant Contact Eric Stookey
Correspondent
Mcra, LLC
1050 K St. NW
Suite 1000
Washington,  DC  20005
Correspondent Contact Hollace Saas Rhodes
Regulation Number888.3360
Classification Product Code
KWL  
Subsequent Product Code
KWY  
Date Received07/24/2019
Decision Date 08/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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