Cleared Traditional

K113570 - INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP

K113570 · Integra Burlington Ma, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
82d
Days
-
Risk

K113570 is an FDA 510(k) clearance for the INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra Burlington Ma, Inc. (Burlington, US). The FDA issued a Cleared decision on February 22, 2012 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integra Burlington Ma, Inc. devices

FDA 510(k) Submission Details - K113570

510(k) Number K113570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2011
Decision Date February 22, 2012
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 107
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