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FDA 510(k)

KNEE INSTRUMENTATION, CONDYLAR

K-Number: K781091 · 1978-07-17

ApplicantBiomet, Inc.
Decision Date1978-07-17
Product CodeHWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KNEE INSTRUMENTATION, CONDYLAR is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1978-07-17 under 510(k) number K781091. The device is classified under product code HWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KNEE INSTRUMENTATION, CONDYLAR?

KNEE INSTRUMENTATION, CONDYLAR is a medical device that received FDA 510(k) clearance on 1978-07-17. The listed applicant is Biomet, Inc.. The 510(k) number is K781091.

When did KNEE INSTRUMENTATION, CONDYLAR receive FDA 510(k) clearance?

KNEE INSTRUMENTATION, CONDYLAR received FDA 510(k) clearance on 1978-07-17, under 510(k) number K781091.

Who is the listed applicant for KNEE INSTRUMENTATION, CONDYLAR?

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 KNEE INSTRUMENTATION, CONDYLAR?

The FDA product code for KNEE INSTRUMENTATION, CONDYLAR is HWT.

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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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