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FDA 510(k)

MIX EVAC II

K-Number: K854077 · 1986-01-31

ApplicantStryker Corp.
Decision Date1986-01-31
Product CodeJDZ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MIX EVAC II is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1986-01-31 under 510(k) number K854077. The device is classified under product code JDZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MIX EVAC II?

MIX EVAC II is a medical device that received FDA 510(k) clearance on 1986-01-31. The listed applicant is Stryker Corp.. The 510(k) number is K854077.

When did MIX EVAC II receive FDA 510(k) clearance?

MIX EVAC II received FDA 510(k) clearance on 1986-01-31, under 510(k) number K854077.

Who is the listed applicant for MIX EVAC II?

The FDA 510(k) record lists Stryker Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIX EVAC II?

The FDA product code for MIX EVAC II is JDZ.

Other records listing Stryker Corp. as applicant

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Related Devices (Code: JDZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934253EXACTECH ALL POLY ACETABULAR CUPExactech, Inc.K925025PRISM BONE CEMENT MIXING SYSTEMDepuy, Inc.K912190STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYSTStryker Corp.K892937REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTSDentsply Intl.K861086ZIMMER VACUUM MIXING SYSTEMZimmer, Inc.K853310SIMPLEX ENHANCEMENT MIXERHowmedica Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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