Cleared Traditional

HEMASORBPLUS Resorbable Hemostatic Bone Putty

K153317 · Orthocon, Inc. · General & Plastic Surgery
Nov 2016
Decision
378d
Days
Risk

About This 510(k) Submission

K153317 is an FDA 510(k) clearance for the HEMASORBPLUS Resorbable Hemostatic Bone Putty, a Wax, Bone, submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on November 30, 2016, 378 days after receiving the submission on November 18, 2015. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K153317 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2015
Decision Date November 30, 2016
Days to Decision 378 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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