Cleared Traditional

K111741 - INTEGRA(TM) CUSA NXT(TM) BONE TIPS

K111741 · Integra Burlington Ma, Inc. (Formerly Integra Radi · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
63d
Days
-
Risk

K111741 is an FDA 510(k) clearance for the INTEGRA(TM) CUSA NXT(TM) BONE TIPS. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra Burlington Ma, Inc. (Formerly Integra Radi (Burlington, US). The FDA issued a Cleared decision on August 23, 2011 after a review of 63 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.

FDA 510(k) Submission Details - K111741

510(k) Number K111741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2011
Decision Date August 23, 2011
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 154
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K111741 · INTEGRA(TM) CUSA NXT(TM) BONE TIPS
Download PDF FDA Summary Integra Burlington Ma…