Cleared Traditional

K123243 - HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY (FDA 510(k) Clearance)

K123243 · Orthocon, Inc. · General & Plastic Surgery device

Apr 2013

Decision

170d

Days

—

Risk

K123243 is an FDA 510(k) clearance for the HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY. This device is classified as a Wax, Bone.

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on April 5, 2013, 170 days after receiving the submission on October 17, 2012.

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

Submission Details

510(k) Number	K123243 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 17, 2012
Decision Date	April 05, 2013
Days to Decision	170 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF