ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY (K063330) - FDA 510(k) Clearance

K063330 is an FDA 510(k) clearance for the ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Colts Neck, US). The FDA issued a Cleared decision on November 22, 2006 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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