Cleared Special

HEMASORBPLUS press Resorable Hemostatic Bone Putty

K143069 · Orthocon, Inc. · General & Plastic Surgery
Dec 2014
Decision
56d
Days
Risk

About This 510(k) Submission

K143069 is an FDA 510(k) clearance for the HEMASORBPLUS press Resorable Hemostatic Bone Putty, a Wax, Bone, submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on December 22, 2014, 56 days after receiving the submission on October 27, 2014. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K143069 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2014
Decision Date December 22, 2014
Days to Decision 56 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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