Cleared Special

K112399 - UNITE BIOMATRIX

K112399 · Synovis Orthopedic & Woundcare · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
19d
Days
-
Risk

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.

View all Synovis Orthopedic & Woundcare devices

FDA 510(k) Submission Details - K112399

510(k) Number K112399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2011
Decision Date September 07, 2011
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 115
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