Cleared Traditional

K071813 - MASTERGRAFT PUTTY (FDA 510(k) Clearance)

K071813 · Medtronic Sofamor Danek · Orthopedic device

Nov 2007

Decision

130d

Days

Class 2

Risk

K071813 is an FDA 510(k) clearance for the MASTERGRAFT PUTTY. 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 November 9, 2007, 130 days after receiving the submission on July 2, 2007.

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

Submission Details

510(k) Number	K071813 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 02, 2007
Decision Date	November 09, 2007
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF