S-Core Implant System

Fastener, Fixation, Nondegradable, Soft Tissue

Subchondral Solutions, Inc.

The following data is part of a premarket notification filed by Subchondral Solutions, Inc. with the FDA for S-core Implant System.

Pre-market Notification Details

Device IDK220901
510k NumberK220901
Device Name:S-Core Implant System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Subchondral Solutions, Inc. 7146 Edinger Ave. Suite A Huntington Beach,  CA  92647
ContactMichael Kolber
CorrespondentMichael Kolber
Subchondral Solutions, Inc. 7146 Edinger Ave. Suite A Huntington Beach,  CA  92647
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-07-29

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