Cleared Traditional

K012506 - MASTERGRAFT RESORBABLE CERAMIC GRANULES (FDA 510(k) Clearance)

K012506 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device

Mar 2002

Decision

213d

Days

Class 2

Risk

K012506 is an FDA 510(k) clearance for the MASTERGRAFT RESORBABLE CERAMIC GRANULES. 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 March 7, 2002, 213 days after receiving the submission on August 6, 2001.

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

Submission Details

510(k) Number	K012506 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 06, 2001
Decision Date	March 07, 2002
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF