Cleared Traditional

K141502 - HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY (FDA 510(k) Clearance)

K141502 · Orthocon, Inc. · General & Plastic Surgery device

Oct 2014

Decision

119d

Days

—

Risk

K141502 is an FDA 510(k) clearance for the HBP4 HARDENING, 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 October 3, 2014, 119 days after receiving the submission on June 6, 2014.

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

Submission Details

510(k) Number	K141502 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 06, 2014
Decision Date	October 03, 2014
Days to Decision	119 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF