Cleared Traditional

K131673 - MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT (FDA 510(k) Clearance)

K131673 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device

Oct 2013

Decision

118d

Days

Class 2

Risk

K131673 is an FDA 510(k) clearance for the MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on October 3, 2013, 118 days after receiving the submission on June 7, 2013.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K131673 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 07, 2013
Decision Date	October 03, 2013
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF