Cleared Traditional

K100205 - FRONTIER DEVICES NEURO SYSTEM

K100205 is an FDA 510(k) clearance for FRONTIER DEVICES NEURO SYSTEM, manufactured by Folsom Metal Products, Inc.. The device is a Class 2 Neurology device with product code GWO cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K100205 · Folsom Metal Products, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
322d
Days
Class 2
Risk

K100205 is an FDA 510(k) clearance for the FRONTIER DEVICES NEURO SYSTEM. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Folsom Metal Products, Inc. (Pelham, US). The FDA issued a Cleared decision on December 13, 2010 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Folsom Metal Products, Inc. devices

FDA 510(k) Submission Details - K100205

510(k) Number K100205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2010
Decision Date December 13, 2010
Days to Decision 322 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 148d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWO Device Classification - Class 2, Special Controls

Product Code GWO Plate, Cranioplasty, Preformed, Alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWO Plate, Cranioplasty, Preformed, Alterable

All 36
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K100205.
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