Cleared Traditional

K090581 - TANTALUM BEAD SET, MODEL P003175

K090581 is an FDA 510(k) clearance for TANTALUM BEAD SET, manufactured by Halifax Biomedical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K090581 · 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
Aug 2009
Decision
171d
Days
Class 2
Risk

K090581 is an FDA 510(k) clearance for the TANTALUM BEAD SET, MODEL P003175. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Halifax Biomedical, Inc. (Dundas, CA). The FDA issued a Cleared decision on August 21, 2009 after a review of 171 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K090581

510(k) Number K090581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2009
Decision Date August 21, 2009
Days to Decision 171 days
Submission Type Traditional
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
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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K090581 · TANTALUM BEAD SET, MODEL P003175
Download PDF FDA Summary Halifax Biomedical, I…