Cleared Traditional

K861086 - ZIMMER VACUUM MIXING SYSTEM (FDA 510(k) Clearance)

K861086 · Zimmer, Inc. · Orthopedic device

Apr 1986

Decision

24d

Days

Class 1

Risk

K861086 is an FDA 510(k) clearance for the ZIMMER VACUUM MIXING SYSTEM. This device is classified as a Mixer, Cement, For Clinical Use (Class I - General Controls, product code JDZ).

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 14, 1986, 24 days after receiving the submission on March 21, 1986.

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

Submission Details

510(k) Number	K861086 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 21, 1986
Decision Date	April 14, 1986
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—