Cleared Traditional

K020078 - EXACTECH RESORBABLE BONE PASTE (FDA 510(k) Clearance)

K020078 · Exactech, Inc. · Orthopedic device

Feb 2004

Decision

779d

Days

Class 2

Risk

K020078 is an FDA 510(k) clearance for the EXACTECH RESORBABLE BONE PASTE. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on February 27, 2004, 779 days after receiving the submission on January 9, 2002.

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

Submission Details

510(k) Number	K020078 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 09, 2002
Decision Date	February 27, 2004
Days to Decision	779 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF