Cleared Traditional

K934253 - EXACTECH ALL POLY ACETABULAR CUP (FDA 510(k) Clearance)

K934253 · Exactech, Inc. · Orthopedic device

Apr 1994

Decision

241d

Days

Class 1

Risk

K934253 is an FDA 510(k) clearance for the EXACTECH ALL POLY ACETABULAR CUP. This device is classified as a Mixer, Cement, For Clinical Use (Class I - General Controls, product code JDZ).

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on April 29, 1994, 241 days after receiving the submission on August 31, 1993.

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

Submission Details

510(k) Number	K934253 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 31, 1993
Decision Date	April 29, 1994
Days to Decision	241 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF