Cleared Traditional

K122156 - ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY (FDA 510(k) Clearance)

K122156 · Orthocon, Inc. · General & Plastic Surgery device

Jan 2013

Decision

192d

Days

—

Risk

K122156 is an FDA 510(k) clearance for the ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY. This device is classified as a Wax, Bone.

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on January 28, 2013, 192 days after receiving the submission on July 20, 2012.

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

Submission Details

510(k) Number	K122156 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 20, 2012
Decision Date	January 28, 2013
Days to Decision	192 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF