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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 K231556
Device Name SPECTRUM® GV Bone Cement
Applicant
Osteoremedies, LLC
6800 Poplar Ave.
Suite 120
Memphis,  TN  38138
Applicant Contact Eric Stookey
Correspondent
Mcra, LLC
803 7th Steet, NW
Washington,  DC  20001
Correspondent Contact Hollace Rhodes
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received05/30/2023
Decision Date 12/20/2023
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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