Cleared Traditional

K202363 - HBP7 Settable Hemostatic Bone Putty (FDA 510(k) Clearance)

K202363 · Orthocon, Inc. · General & Plastic Surgery device

Jan 2021

Decision

153d

Days

—

Risk

K202363 is an FDA 510(k) clearance for the HBP7 Settable Hemostatic Bone Putty. This device is classified as a Wax, Bone.

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on January 19, 2021, 153 days after receiving the submission on August 19, 2020.

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

Submission Details

510(k) Number	K202363 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 19, 2020
Decision Date	January 19, 2021
Days to Decision	153 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF