Cleared Traditional

ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM (K060346) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060346 · Ultrazonix Dnt AB · General & Plastic Surgery device
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Dec 2006
Decision
315d
Days
Class 2
Risk

K060346 is an FDA 510(k) clearance for the ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM. Classified as System, Ablation, Ultrasound And Accessories (product code NTB), Class II - Special Controls.

Submitted by Ultrazonix Dnt AB (Minneapolis, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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. Elevated predicate reliance profile. 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.

View all Ultrazonix Dnt AB devices

Submission Details

510(k) Number K060346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2006
Decision Date December 22, 2006
Days to Decision 315 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 115d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTB System, Ablation, Ultrasound And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Intended For Use As A Surgical Tool For Coagulation And Ablation Of Soft Tissue. This Differs From The Description In The Regulation In That This Device Is Not Intended To Cut Tissue And This Device Uses High Intensity Ultrasound Energy Instead Of Electrosurgery Or Electrocautery.
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.