Cleared Traditional

K072265 - PROGENIX DMB PUTTY (FDA 510(k) Clearance)

K072265 · Medtronic Sofamor Danek · Orthopedic device

Jan 2008

Decision

147d

Days

Class 2

Risk

K072265 is an FDA 510(k) clearance for the PROGENIX DMB 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 January 9, 2008, 147 days after receiving the submission on August 15, 2007.

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

Submission Details

510(k) Number	K072265 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 15, 2007
Decision Date	January 09, 2008
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF