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FDA 510(k)

S-Core Implant System

K-Number: K220901 · 2022-07-29

ApplicantSubchondral Solutions, Inc.
Decision Date2022-07-29
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

S-Core Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Subchondral Solutions, Inc.. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K220901. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-Core Implant System?

S-Core Implant System is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Subchondral Solutions, Inc.. The 510(k) number is K220901.

When did S-Core Implant System receive FDA 510(k) clearance?

S-Core Implant System received FDA 510(k) clearance on 2022-07-29, under 510(k) number K220901.

Who is the listed applicant for S-Core Implant System?

The FDA 510(k) record lists Subchondral Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-Core Implant System?

The FDA product code for S-Core Implant System is MBI.

Other records listing Subchondral Solutions, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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