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Difusion Technologies

FDA Regulatory Profile

Difusion Technologies has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 12, 2026 · NAI
Latest 510(k)
Nov 1, 2019

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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
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 12, 2026Austin, TXDevicesNo Action Indicated (NAI)3009336374

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
K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemNov 1, 2019
K123969XIPHOSFeb 7, 2013
K100042DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEMOct 1, 2010

FDA data resources