Cleared Traditional

MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP

K141824 · Medtronic Sofamor Danek, Inc. · Orthopedic
Sep 2014
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K141824 is an FDA 510(k) clearance for the MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on September 5, 2014, 60 days after receiving the submission on July 7, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K141824 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2014
Decision Date September 05, 2014
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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