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FDA 510(k)

UNIVERSAL BONE CEMENT KIT

K-Number: K931540 · 1994-01-27

ApplicantBiodynamic Technologies, Inc.
Decision Date1994-01-27
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL BONE CEMENT KIT 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 1994-01-27 under 510(k) number K931540. The device is classified under product code LZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL BONE CEMENT KIT?

UNIVERSAL BONE CEMENT KIT is a medical device that received FDA 510(k) clearance on 1994-01-27. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K931540.

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

UNIVERSAL BONE CEMENT KIT received FDA 510(k) clearance on 1994-01-27, under 510(k) number K931540.

Who is the listed applicant for UNIVERSAL BONE CEMENT KIT?

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 UNIVERSAL BONE CEMENT KIT?

The FDA product code for UNIVERSAL BONE CEMENT KIT is LZN.

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Related Devices (Code: LZN)

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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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