Cleared Traditional

K903485 - TITANIUM MESH

K903485 is an FDA 510(k) clearance for TITANIUM MESH, manufactured by Ruggles Corp.. The device is a Class 2 Neurology device with product code GWO cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K903485 · Ruggles Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
205d
Days
Class 2
Risk

K903485 is an FDA 510(k) clearance for the TITANIUM MESH. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Ruggles Corp. (No. Quincy, US). The FDA issued a Cleared decision on February 21, 1991 after a review of 205 days - an extended review cycle.

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. Standard predicate reliance. 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 Ruggles Corp. devices

FDA 510(k) Submission Details - K903485

510(k) Number K903485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date February 21, 1991
Days to Decision 205 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 148d · This submission: 205d
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 40
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K903485.
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
K073006 · Takiron Co., Ltd. · May 2008
SYNTHES (USA) 2.0MM TITANIUM T-PLATE
K072758 · Synthes (Usa) · Dec 2007
SYNTHES CRANIAL SPRING CLIP (CSC)
K974206 · Synthes (Usa) · Mar 1998
MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
K861822 · Valley Forge Scientific Corp. · Jul 1986
RION AUDIOMETER AA-67
K812951 · Rion Acoustic Instruments, Inc. · Nov 1981
RION AUDIOMETER AA-68
K812952 · Rion Acoustic Instruments, Inc. · Nov 1981