Cleared Special

K103417 - HALIFAX BIOMEDICAL TANATLUM BEAD SET (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K103417 · Halifax Biomedical, Inc. · General & Plastic Surgery device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 132d · This submission: 218d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 7
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