Cleared Traditional

K082166 - MASTERGRAFT STRIP (FDA 510(k) Clearance)

K082166 · Medtronic Sofamor Danek · Orthopedic device

Jun 2009

Decision

306d

Days

Class 2

Risk

K082166 is an FDA 510(k) clearance for the MASTERGRAFT STRIP. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on June 2, 2009, 306 days after receiving the submission on July 31, 2008.

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

Submission Details

510(k) Number	K082166 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 31, 2008
Decision Date	June 02, 2009
Days to Decision	306 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF