Cleared Traditional

K193052 - HBP6 Settable, Resorbable Hemostatic Bone Paste (FDA 510(k) Clearance)

K193052 · Orthocon, Inc. · General & Plastic Surgery device

Mar 2020

Decision

147d

Days

—

Risk

K193052 is an FDA 510(k) clearance for the HBP6 Settable, Resorbable Hemostatic Bone Paste. This device is classified as a Wax, Bone.

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on March 27, 2020, 147 days after receiving the submission on November 1, 2019.

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

Submission Details

510(k) Number	K193052 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 01, 2019
Decision Date	March 27, 2020
Days to Decision	147 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF