Cleared Traditional

K925025 - PRISM BONE CEMENT MIXING SYSTEM (FDA 510(k) Clearance)

K925025 · Depuy, Inc. · Orthopedic device

Jan 1994

Decision

460d

Days

Class 1

Risk

K925025 is an FDA 510(k) clearance for the PRISM BONE CEMENT MIXING SYSTEM. This device is classified as a Mixer, Cement, For Clinical Use (Class I - General Controls, product code JDZ).

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 5, 1994, 460 days after receiving the submission on October 2, 1992.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4210.

Submission Details

510(k) Number	K925025 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 02, 1992
Decision Date	January 05, 1994
Days to Decision	460 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement