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Wiltrom Corporation Limited

FDA Regulatory Profile

Wiltrom Corporation Limited has 0 FDA recalls, 2 inspections, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 6, 2025 · VAI
Latest 510(k)
Oct 23, 2020

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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) clearances5Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 6, 2025Zhubei City, TaiwanDevicesVoluntary Action Indicated (VAI)3011964577
Sep 8, 2016Hsinchu, TaiwanDevicesVoluntary Action Indicated (VAI)3010191241

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
K202894Wiltrom Spinal Fixation SystemOct 23, 2020
K180758Osteocera Resorbable Bone SubstituteOct 24, 2018
K172237Bicera Resorbable Bone SubstituteFeb 2, 2018
K172548Wiltrom Spinal Fixation SystemJan 12, 2018
K110949BICERA (TM) RESORBABLE BONE SUBSTITUTESep 18, 2012

FDA data resources