Cleared Special

K031034 - SPIN DOWN RAPIDFLAP

K031034 is the FDA 510(k) clearance for SPIN DOWN RAPIDFLAP by Walter Lorenz Surgical, Inc.. It is a Class 2 Neurology device (product code GXN) cleared through the Special 510(k) pathway after a 50-day FDA review.

K031034 · Walter Lorenz Surgical, Inc. · Neurology device
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May 2003
Decision
50d
Days
Class 2
Risk

K031034 is an FDA 510(k) clearance for the SPIN DOWN RAPIDFLAP. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 21, 2003 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Walter Lorenz Surgical, Inc. devices

Submission Details

510(k) Number K031034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2003
Decision Date May 21, 2003
Days to Decision 50 days
Submission Type Special
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
98d faster than avg
Panel avg: 148d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
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 - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 33
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K031034.
PATIENT CONTOURED MESH (PCM)
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SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K033868 · Synthes (Usa) · Jun 2004
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
K030378 · Stryker Instruments · Mar 2003
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
K993990 · Stryker Instruments · Feb 2000
SYNTHES CRANIAL FLAP TWIST CLAMP
K991860 · Synthes (Usa) · Jul 1999