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Intelligent Implant Systems, LLC

FDA Regulatory Profile

Intelligent Implant Systems, LLC has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 16, 2018 · VAI
Latest 510(k)
Apr 16, 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) clearances6Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 16, 2018Charlotte, NCDevicesVoluntary Action Indicated (VAI)3011121367

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
K173935Mediant Anterior Cervical Plating SystemApr 16, 2018
K163056Revolution™ Spinal Fixation SystemFeb 24, 2017
K160216Revolution Spinal Fixation SystemApr 22, 2016
K142939Revolution Spinal Fixation SystemJan 13, 2015
K132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMOct 25, 2013
K121682ACTIVE SCREW BONE SCREWOct 4, 2012

FDA data resources