Cleared Traditional

K111575 - HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX (FDA 510(k) Clearance)

K111575 · Orthocon, Inc. · General & Plastic Surgery device

May 2012

Decision

352d

Days

—

Risk

K111575 is an FDA 510(k) clearance for the HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX. This device is classified as a Wax, Bone.

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on May 23, 2012, 352 days after receiving the submission on June 6, 2011.

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

Submission Details

510(k) Number	K111575 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 06, 2011
Decision Date	May 23, 2012
Days to Decision	352 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF