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Subchondral Solutions, Inc.

FDA Regulatory Profile

Subchondral Solutions, Inc. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 24, 2025 · NAI
Latest 510(k)
Jul 29, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 24, 2025Costa Mesa, CADevicesNo Action Indicated (NAI)3016660811
Dec 8, 2021Costa Mesa, CADevicesNo Action Indicated (NAI)3016660811

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K220901S-Core Implant SystemJul 29, 2022
K191995S4 Screw SystemApr 18, 2020
K162171S4 Screw System™Sep 7, 2017

FDA data resources