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FDA 510(k)

HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT

K-Number: K881983 · 1988-10-06

ApplicantHowmedica Corp.
Decision Date1988-10-06
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1988-10-06 under 510(k) number K881983. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT?

HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is Howmedica Corp.. The 510(k) number is K881983.

When did HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT receive FDA 510(k) clearance?

HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT received FDA 510(k) clearance on 1988-10-06, under 510(k) number K881983.

Who is the listed applicant for HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT?

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 PRECISION OSTEOLOCK FEMORAL COMPONENT?

The FDA product code for HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT is LWJ.

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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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Related Devices (Code: LWJ)

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.

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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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