Intellitorq— 510(k) K180092

Name: FDA 510(k) clearance K180092
Creator: U.S. Food and Drug Administration
Published: 2018-03-08

Substantially Equivalent

Gauthier Biomedical, Inc.

FDA 510(k) clearance K180092 for Intellitorq, Substantially Equivalent on 2018-03-08. Applicant: Gauthier Biomedical, Inc.. Device class: 1.

Clearance details

Applicant: Gauthier Biomedical, Inc.
Product code: Code HXC
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 2018-01-12
Decision date: 2018-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grafton, WI, US

Download summary PDF View on FDA.gov ↗

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K813067 — SPINAL WRENCH1981-11-24
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Adverse events under product code HXC

product code HXC

Malfunction: 851
Total: 851

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.