Cleared Special

K014148 - SELF-DRILLING RADIOGRAPHIC MARKER

K014148 is an FDA 510(k) clearance for SELF-DRILLING RADIOGRAPHIC MARKER, manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 30-day FDA review.

K014148 · Walter Lorenz Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jan 2002
Decision
30d
Days
Class 2
Risk

K014148 is an FDA 510(k) clearance for the SELF-DRILLING RADIOGRAPHIC MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 17, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery 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 - K014148

510(k) Number K014148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2001
Decision Date January 17, 2002
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

NEU Device Classification - Class 2, Special Controls

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEU Marker, Radiographic, Implantable

All 92
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K014148.
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K020276 · Ethicon Endo-Surgery, Inc. · Apr 2002
MICROMARK II TISSUE MARKER,MODEL C1535
K013413 · Ethicon Endo-Surgery, Inc. · Dec 2001
RADIOGRAPHIC MARKERS
K011856 · Encore Orthopedics, Inc. · Aug 2001
TANTALUM BEADS - RADIOGRAPHIC MARKER
K010348 · Biomet, Inc. · May 2001