Cleared Traditional

K033611 - CALCIGEN -NAP BONE VOID FILLER (FDA 510(k) Clearance)

K033611 · Biomet, Inc. · Orthopedic device

Apr 2004

Decision

162d

Days

Class 2

Risk

K033611 is an FDA 510(k) clearance for the CALCIGEN -NAP BONE VOID FILLER. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 27, 2004, 162 days after receiving the submission on November 17, 2003.

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

Submission Details

510(k) Number	K033611 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 17, 2003
Decision Date	April 27, 2004
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF