Cleared Traditional

K102762 - ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR (FDA 510(k) Clearance)

K102762 · Orthocon, Inc. · General & Plastic Surgery device

Feb 2011

Decision

144d

Days

—

Risk

K102762 is an FDA 510(k) clearance for the ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR. This device is classified as a Wax, Bone.

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on February 15, 2011, 144 days after receiving the submission on September 24, 2010.

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

Submission Details

510(k) Number	K102762 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 2010
Decision Date	February 15, 2011
Days to Decision	144 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF