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Benvenue Medical, Inc.

FDA Regulatory Profile

Benvenue Medical, Inc. has 0 FDA recalls, 1 inspection, 8 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 25, 2013 · NAI
Latest 510(k)
Oct 21, 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) clearances8Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 25, 2013Santa Clara, CADevicesNo Action Indicated (NAI)3007047261

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
K201427Trivergent Spinal Fixation SystemOct 21, 2020
K193172Luna XD Ti Interbody Fusion SystemJul 2, 2020
K183560Luna 3D GEN2 Interbody Fusion SystemMay 23, 2019
K162431Luna 3D Interbody Fusion SystemNov 17, 2016
K142023LUNA INTERBODY SYSTEMNov 20, 2014
K141141KIVA VCF TREATMENT SYSTEMAug 14, 2014
K132817KIVA VCF TREATMENT SYSTEMJan 24, 2014
K070293BENVENUE VCF OSTEO COIL SYSTEMJul 10, 2007

FDA data resources