Cleared Traditional

K023553 - MASTERGRAFT MATRIX (FDA 510(k) Clearance)

K023553 · Medtronic Sofamor Danek, Inc. · Orthopedic device

Apr 2003

Decision

181d

Days

Class 2

Risk

K023553 is an FDA 510(k) clearance for the MASTERGRAFT MATRIX. This device is classified as 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 April 22, 2003, 181 days after receiving the submission on October 23, 2002.

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

Submission Details

510(k) Number	K023553 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 23, 2002
Decision Date	April 22, 2003
Days to Decision	181 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF