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Diamond Orthopedic, LLC

FDA Regulatory Profile

Diamond Orthopedic, LLC has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Feb 15, 2024 · NAI
Latest 510(k)
May 9, 2018

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 15, 2024Gastonia, NCDevicesNo Action Indicated (NAI)3013540005
Apr 5, 2019Gastonia, NCDevicesVoluntary Action Indicated (VAI)3013540005

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
K180932Diamond Orthopedic Bone Fixation Screws and PinsMay 9, 2018

FDA data resources