Cleared Special

K112849 - FIXATE TISSUE BAND

K112849 is the FDA 510(k) clearance for FIXATE TISSUE BAND by Anulex Technologies, Inc.. It is a Class 2 General & Plastic Surgery device (product code GZB) cleared through the Special 510(k) pathway after a 28-day FDA review.

K112849 · Anulex Technologies, Inc. · General & Plastic Surgery device
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Oct 2011
Decision
28d
Days
Class 2
Risk

K112849 is an FDA 510(k) clearance for the FIXATE TISSUE BAND. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Anulex Technologies, Inc. (Minnetonka, US). The FDA issued a Cleared decision on October 27, 2011 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 882.5880 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Anulex Technologies, Inc. devices

Submission Details

510(k) Number K112849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2011
Decision Date October 27, 2011
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

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