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FDA 510(k)

MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL

K-Number: K894149 · 1989-09-14

ApplicantHowmedica Corp.
Decision Date1989-09-14
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1989-09-14 under 510(k) number K894149. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL?

MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL is a medical device that received FDA 510(k) clearance on 1989-09-14. The listed applicant is Howmedica Corp.. The 510(k) number is K894149.

When did MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL receive FDA 510(k) clearance?

MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL received FDA 510(k) clearance on 1989-09-14, under 510(k) number K894149.

Who is the listed applicant for MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL?

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 MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL?

The FDA product code for MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL is JDI.

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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: JDI)

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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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