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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 a medical device manufactured by Subchondral Solutions, Inc.. It received FDA 510(k) clearance on 2022-07-29 under approval 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. It is manufactured by Subchondral Solutions, Inc.. The 510(k) number is K220901.

When was S-Core Implant System approved by the FDA?

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

What company makes S-Core Implant System?

S-Core Implant System is manufactured by Subchondral Solutions, Inc..

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

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

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Subchondral Solutions, Inc.

K191995S4 Screw System

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Official Source

View on FDA Database →

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

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