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FDA 510(k)

COMPRESSION MOLDING OF UHMWPE

K-Number: K801313 · 1980-06-09

ApplicantHowmedica Corp.
Decision Date1980-06-09
Product Code
DecisionSubstantially Equivalent

Device Summary

COMPRESSION MOLDING OF UHMWPE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1980-06-09 under 510(k) number K801313. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPRESSION MOLDING OF UHMWPE?

COMPRESSION MOLDING OF UHMWPE is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Howmedica Corp.. The 510(k) number is K801313.

When did COMPRESSION MOLDING OF UHMWPE receive FDA 510(k) clearance?

COMPRESSION MOLDING OF UHMWPE received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801313.

Who is the listed applicant for COMPRESSION MOLDING OF UHMWPE?

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

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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