FRONTIER DEVICES NEURO SYSTEM— 510(k) K100205

Name: FDA 510(k) clearance K100205
Creator: U.S. Food and Drug Administration
Published: 2010-12-13

Substantially Equivalent

Folsom Metal Products, Inc.

FDA 510(k) clearance K100205 for FRONTIER DEVICES NEURO SYSTEM, Substantially Equivalent on 2010-12-13. Applicant: Folsom Metal Products, Inc.. Device class: 2.

Clearance details

Applicant: Folsom Metal Products, Inc.
Product code: Code GWO
Device class: Class 2
Regulation: 21 CFR 882.5320
Advisory panel: Neurology
Date received: 2010-01-25
Decision date: 2010-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pelham, AL, US

Download summary PDF View on FDA.gov ↗

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K231834 — VSP PEEK Cranial Implant2024-04-04

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.