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FDA 510(k)

STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST

K-Number: K912190 · 1991-08-29

ApplicantStryker Corp.
Decision Date1991-08-29
Product CodeJDZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1991-08-29 under 510(k) number K912190. The device is classified under product code JDZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST?

STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST is a medical device that received FDA 510(k) clearance on 1991-08-29. The listed applicant is Stryker Corp.. The 510(k) number is K912190.

When did STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST receive FDA 510(k) clearance?

STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST received FDA 510(k) clearance on 1991-08-29, under 510(k) number K912190.

Who is the listed applicant for STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST?

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 STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST?

The FDA product code for STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST is JDZ.

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Other records listing Stryker Corp. as applicant

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.

K230045HipCheckK191259Stryker CrossFlow Integrated Arthroscopy PumpK182359HipCheckK122113MEMORY METAL STAPLES, EASYCLIPK122053SHAPEMATCH CUTTING GUIDEK122284HOFFMANN 3

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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.K892937REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTSDentsply Intl.K861086ZIMMER VACUUM MIXING SYSTEMZimmer, Inc.K854077MIX EVAC IIStryker Corp.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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