K112399 - UNITE BIOMATRIX (FDA 510(k) Clearance)

K112399 is an FDA 510(k) clearance for the UNITE BIOMATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Synovis Orthopedic & Woundcare (Irvine, US). The FDA issued a Cleared decision on September 7, 2011 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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