Cleared Traditional

HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY

K141502 · Orthocon, Inc. · General & Plastic Surgery
Oct 2014
Decision
119d
Days
Risk

About This 510(k) Submission

K141502 is an FDA 510(k) clearance for the HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY, 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 review panel.

Submission Details

510(k) Number K141502 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MTJ — Wax, Bone
Device Class

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