Cannulated Hemi Implant— 510(k) K190543

Name: FDA 510(k) clearance K190543
Creator: U.S. Food and Drug Administration
Published: 2019-05-31

Substantially Equivalent

Vilex IN Tennessee, Inc.

FDA 510(k) clearance K190543 for Cannulated Hemi Implant, Substantially Equivalent on 2019-05-31. Applicant: Vilex IN Tennessee, Inc.. Device class: 2.

Clearance details

Applicant: Vilex IN Tennessee, Inc.
Product code: Code KWD
Device class: Class 2
Regulation: 21 CFR 888.3730
Advisory panel: Orthopedic
Date received: 2019-03-04
Decision date: 2019-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcminnville, TN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.