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FDA 510(k)

TYPE 3 FEMORAL COMPONENTS

K-Number: K983404 · 1998-12-22

ApplicantHowmedica Corp.
Decision Date1998-12-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TYPE 3 FEMORAL COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K983404. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYPE 3 FEMORAL COMPONENTS?

TYPE 3 FEMORAL COMPONENTS is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Howmedica Corp.. The 510(k) number is K983404.

When did TYPE 3 FEMORAL COMPONENTS receive FDA 510(k) clearance?

TYPE 3 FEMORAL COMPONENTS received FDA 510(k) clearance on 1998-12-22, under 510(k) number K983404.

Who is the listed applicant for TYPE 3 FEMORAL COMPONENTS?

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 TYPE 3 FEMORAL COMPONENTS?

The FDA product code for TYPE 3 FEMORAL COMPONENTS is LZO.

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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 MESHK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATIONK983419HOFFMANN II MIAMI POST

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Related Devices (Code: LZO)

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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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