Cleared Special

AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY

K140117 · Orthocon, Inc. · General & Plastic Surgery
Feb 2014
Decision
26d
Days
Risk

About This 510(k) Submission

K140117 is an FDA 510(k) clearance for the AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY, a Wax, Bone, submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on February 11, 2014, 26 days after receiving the submission on January 16, 2014. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K140117 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2014
Decision Date February 11, 2014
Days to Decision 26 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MTJ — Wax, Bone
Device Class

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