AEON-C Stand Alone System— 510(k) K191477

Clearance details

Applicant

Huvexel Co. , Ltd.

Product code

Code OVE

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2019-06-04

Decision date

2019-11-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Seongnam-Si, KR

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Injury

293

Malfunction

710

Total

1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →