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FDA 510(k)

KENNEDY TIBIAL COMPONENT

K-Number: K831513 · 1983-07-28

ApplicantBiomet, Inc.
Decision Date1983-07-28
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KENNEDY TIBIAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1983-07-28 under 510(k) number K831513. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENNEDY TIBIAL COMPONENT?

KENNEDY TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 1983-07-28. The listed applicant is Biomet, Inc.. The 510(k) number is K831513.

When did KENNEDY TIBIAL COMPONENT receive FDA 510(k) clearance?

KENNEDY TIBIAL COMPONENT received FDA 510(k) clearance on 1983-07-28, under 510(k) number K831513.

Who is the listed applicant for KENNEDY TIBIAL COMPONENT?

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

What is the FDA product code for KENNEDY TIBIAL COMPONENT?

The FDA product code for KENNEDY TIBIAL COMPONENT is HSX.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: HSX)

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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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