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Iconn Orthopedics, LLC

FDA Regulatory Profile

Iconn Orthopedics, LLC has 0 FDA recalls, 3 inspections, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 18, 2025 · NAI
Latest 510(k)
Dec 7, 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) clearances5Oct 4, 2026Not statedCurrent
Inspections3Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 18, 2025Birmingham, ALDevicesNo Action Indicated (NAI)3010887276
Mar 30, 2017Birmingham, ALDevicesNo Action Indicated (NAI)3010887276
Nov 5, 2014Birmingham, ALDevicesNo Action Indicated (NAI)3010887276

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
K180670ICONN Campbell Interference ScrewDec 7, 2018
K182264ICONN Revolution Knotless Suture AnchorOct 19, 2018
K181680ICONN Answer II Suture AnchorAug 9, 2018
K172491ICONN Square 2.5MM Suture AnchorNov 29, 2017
K132724ICONN ANSWER SUTURE ANCHORApr 17, 2014

FDA data resources