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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K220901
Device Name S-Core Implant System
Applicant
Subchondral Solutions, Inc.
7146 Edinger Ave. Suite A
Huntington Beach,  CA  92647
Applicant Contact Michael Kolber
Correspondent
Subchondral Solutions, Inc.
7146 Edinger Ave. Suite A
Huntington Beach,  CA  92647
Correspondent Contact Michael Kolber
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received03/28/2022
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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