Cleared Special

K991029 - RAPIDFLAP CRANIAL CLAMP

K991029 is an FDA 510(k) clearance for RAPIDFLAP CRANIAL CLAMP, manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Neurology device with product code GXN cleared through the Special 510(k) pathway after a 25-day FDA review.

K991029 · Walter Lorenz Surgical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
25d
Days
Class 2
Risk

K991029 is an FDA 510(k) clearance for the RAPIDFLAP CRANIAL CLAMP. 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 April 23, 1999 after a review of 25 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

FDA 510(k) Submission Details - K991029

510(k) Number K991029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date April 23, 1999
Days to Decision 25 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
123d faster than avg
Panel avg: 148d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

GXN Device Classification - Class 2, Special Controls

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 55
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K991029.
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
K993990 · Stryker Instruments · Feb 2000
SYNTHES CRANIAL FLAP TWIST CLAMP
K991860 · Synthes (Usa) · Jul 1999
SYNTHES CRANIAL FLAP TUBE CLAMP
K992000 · Synthes (Usa) · Jul 1999
SEVRAIN CRANIAL CLAMP
K971252 · Ikonos Corp. · Jul 1998
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
K971408 · Ikonos Corp. · May 1998
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
K972332 · Aesculap, Inc. · Jan 1998