Cleared Traditional

K020986 - MASTERGRAFT RESORBABLE CERAMIC (FDA 510(k) Clearance)

K020986 · Medtronic Sofamor Danek, Inc. · Orthopedic device

Jul 2002

Decision

117d

Days

Class 2

Risk

K020986 is an FDA 510(k) clearance for the MASTERGRAFT RESORBABLE CERAMIC. 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 July 22, 2002, 117 days after receiving the submission on March 27, 2002.

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

Submission Details

510(k) Number	K020986 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 27, 2002
Decision Date	July 22, 2002
Days to Decision	117 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF