Cleared Traditional

K030178 - CALCIGEN PSI BONE GRAFT SUBSTITUTE (FDA 510(k) Clearance)

K030178 · Biomet, Inc. · Orthopedic device

Feb 2003

Decision

40d

Days

Class 2

Risk

K030178 is an FDA 510(k) clearance for the CALCIGEN PSI BONE GRAFT SUBSTITUTE. 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 February 26, 2003, 40 days after receiving the submission on January 17, 2003.

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

Submission Details

510(k) Number	K030178 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 17, 2003
Decision Date	February 26, 2003
Days to Decision	40 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF