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FDA 510(k)

PRE-STERILIZATION OF VITALLIUM ALLOY

K-Number: K820218 · 1982-06-03

ApplicantHowmedica Corp.
Decision Date1982-06-03
Product Code
DecisionSubstantially Equivalent

Device Summary

PRE-STERILIZATION OF VITALLIUM ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1982-06-03 under 510(k) number K820218. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-STERILIZATION OF VITALLIUM ALLOY?

PRE-STERILIZATION OF VITALLIUM ALLOY is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Howmedica Corp.. The 510(k) number is K820218.

When did PRE-STERILIZATION OF VITALLIUM ALLOY receive FDA 510(k) clearance?

PRE-STERILIZATION OF VITALLIUM ALLOY received FDA 510(k) clearance on 1982-06-03, under 510(k) number K820218.

Who is the listed applicant for PRE-STERILIZATION OF VITALLIUM ALLOY?

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

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Other records listing Howmedica Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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