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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 K262290
Device Name REMEDY POLY+PLUS SNAP FIT Acetabular Cup
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 Received07/06/2026
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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