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FDA 510(k)

BI-CENTRIC BI-POLAR ENDOPROSTHESIS

K-Number: K810062 · 1981-01-26

ApplicantHowmedica Corp.
Decision Date1981-01-26
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BI-CENTRIC BI-POLAR ENDOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1981-01-26 under 510(k) number K810062. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI-CENTRIC BI-POLAR ENDOPROSTHESIS?

BI-CENTRIC BI-POLAR ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Howmedica Corp.. The 510(k) number is K810062.

When did BI-CENTRIC BI-POLAR ENDOPROSTHESIS receive FDA 510(k) clearance?

BI-CENTRIC BI-POLAR ENDOPROSTHESIS received FDA 510(k) clearance on 1981-01-26, under 510(k) number K810062.

Who is the listed applicant for BI-CENTRIC BI-POLAR ENDOPROSTHESIS?

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

What is the FDA product code for BI-CENTRIC BI-POLAR ENDOPROSTHESIS?

The FDA product code for BI-CENTRIC BI-POLAR ENDOPROSTHESIS is KWY.

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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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