Cleared Special

K103417 - HALIFAX BIOMEDICAL TANATLUM BEAD SET

K103417 is an FDA 510(k) clearance for HALIFAX BIOMEDICAL TANATLUM BEAD SET, manufactured by Halifax Biomedical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 218-day FDA review.

K103417 · Halifax Biomedical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
218d
Days
Class 2
Risk

K103417 is an FDA 510(k) clearance for the HALIFAX BIOMEDICAL TANATLUM BEAD SET. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Halifax Biomedical, Inc. (Lake Hopatcong, US). The FDA issued a Cleared decision on June 28, 2011 after a review of 218 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K103417

510(k) Number K103417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2010
Decision Date June 28, 2011
Days to Decision 218 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
103d slower than avg
Panel avg: 115d · This submission: 218d
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 109
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K102608 · Suros Surgical Systems, Inc. A Hologic Company · Oct 2010
K103417 · HALIFAX BIOMEDICAL TANATLUM BEAD SET
Download PDF FDA Summary Halifax Biomedical, I…