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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K250760
Device Name SPECTRUM GV Bone Cement
Applicant
Osteoremedies, LLC
6800 Poplar Ave.
Suite 120
Memphis,  TN  38138
Applicant Contact Rachel Kennedy
Correspondent
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Danielle Besal
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received03/13/2025
Decision Date 04/02/2025
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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