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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 K252326
Device Name InterSpace GV Hip Spacer
Applicant
Tecres S.P.A.
Via Andrea Doria, 6
Sommacampagna,  IT 37066
Applicant Contact Giuseppe Gazzara
Correspondent
MCRA
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Michael Coladonato
Regulation Number888.3360
Classification Product Code
KWL  
Subsequent Product Codes
KWY   MBB  
Date Received07/25/2025
Decision Date 08/06/2025
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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