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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 K253675
Device Name OsteoRemedies Hip Spacer System
Applicant
Osteoremedies, LLC
6800 Poplar Ave.
#120
Germantown,  TN  38138
Applicant Contact Eric Stookey
Correspondent
MCRA, LLC
803 7th St. NW, 4th Floor
Washington,  DC  20001
Correspondent Contact Hollace Saas Rhodes
Regulation Number888.3360
Classification Product Code
KWL  
Subsequent Product Code
KWY  
Date Received11/21/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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