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FDA 510(k)

THE UNIVERSAL BONE CEMENT RESISTOR

K-Number: K924323 · 1993-02-12

ApplicantBiodynamic Technologies, Inc.
Decision Date1993-02-12
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE UNIVERSAL BONE CEMENT RESISTOR is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamic Technologies, Inc.. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K924323. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE UNIVERSAL BONE CEMENT RESISTOR?

THE UNIVERSAL BONE CEMENT RESISTOR is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K924323.

When did THE UNIVERSAL BONE CEMENT RESISTOR receive FDA 510(k) clearance?

THE UNIVERSAL BONE CEMENT RESISTOR received FDA 510(k) clearance on 1993-02-12, under 510(k) number K924323.

Who is the listed applicant for THE UNIVERSAL BONE CEMENT RESISTOR?

The FDA 510(k) record lists Biodynamic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE UNIVERSAL BONE CEMENT RESISTOR?

The FDA product code for THE UNIVERSAL BONE CEMENT RESISTOR is JDI.

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Official Source

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

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