Cleared Traditional

K010427 - LORENZ FIDUCAIL SCREW

K010427 is the FDA 510(k) clearance for LORENZ FIDUCAIL SCREW by Walter Lorenz Surgical, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K010427 · Walter Lorenz Surgical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
30d
Days
Class 2
Risk

K010427 is an FDA 510(k) clearance for the LORENZ FIDUCAIL SCREW. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 15, 2001 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Walter Lorenz Surgical, Inc. devices

Submission Details

510(k) Number K010427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2001
Decision Date March 15, 2001
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K010427.
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Z-TOUCH
K003268 · Brainlab AG · Feb 2001
STRYKER REMOTE SURGICAL PLANNING SYSTEM
K004027 · Stryker Instruments · Jan 2001
STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES
K003111 · Stryker Instruments · Jan 2001