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FDA 510(k)

HOWMEDICA BIPOLAR PROSTHESIS

K-Number: K855231 · 1986-02-27

ApplicantHowmedica Corp.
Decision Date1986-02-27
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA BIPOLAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1986-02-27 under 510(k) number K855231. 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 HOWMEDICA BIPOLAR PROSTHESIS?

HOWMEDICA BIPOLAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 1986-02-27. The listed applicant is Howmedica Corp.. The 510(k) number is K855231.

When did HOWMEDICA BIPOLAR PROSTHESIS receive FDA 510(k) clearance?

HOWMEDICA BIPOLAR PROSTHESIS received FDA 510(k) clearance on 1986-02-27, under 510(k) number K855231.

Who is the listed applicant for HOWMEDICA BIPOLAR PROSTHESIS?

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 HOWMEDICA BIPOLAR PROSTHESIS?

The FDA product code for HOWMEDICA BIPOLAR PROSTHESIS is KWY.

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Other records listing Howmedica Corp. as applicant

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K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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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