Cleared Traditional

K153317 - HEMASORBPLUS Resorbable Hemostatic Bone Putty (FDA 510(k) Clearance)

K153317 · Orthocon, Inc. · General & Plastic Surgery device

Nov 2016

Decision

378d

Days

—

Risk

K153317 is an FDA 510(k) clearance for the HEMASORBPLUS 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 November 30, 2016, 378 days after receiving the submission on November 18, 2015.

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

Submission Details

510(k) Number	K153317 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 18, 2015
Decision Date	November 30, 2016
Days to Decision	378 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF