Cleared Special

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

K063330 · Orthocon, Inc. · General & Plastic Surgery device

Nov 2006

Decision

19d

Days

—

Risk

K063330 is an FDA 510(k) clearance for the ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY. This device is classified as a Wax, Bone.

Submitted by Orthocon, Inc. (Colts Neck, US). The FDA issued a Cleared decision on November 22, 2006, 19 days after receiving the submission on November 3, 2006.

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

Submission Details

510(k) Number	K063330 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 03, 2006
Decision Date	November 22, 2006
Days to Decision	19 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF