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FDA 510(k)

REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS

K-Number: K892937 · 1989-06-22

ApplicantDentsply Intl.
Decision Date1989-06-22
Product CodeJDZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K892937. 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 REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS?

REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is Dentsply Intl.. The 510(k) number is K892937.

When did REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS receive FDA 510(k) clearance?

REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS received FDA 510(k) clearance on 1989-06-22, under 510(k) number K892937.

Who is the listed applicant for REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS?

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

What is the FDA product code for REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS?

The FDA product code for REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS is JDZ.

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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.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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