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FDA 510(k)

PCA +15MM MODULAR FEMORAL HEAD

K-Number: K955305 · 1996-01-18

ApplicantHowmedica Corp.
Decision Date1996-01-18
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PCA +15MM MODULAR FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1996-01-18 under 510(k) number K955305. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCA +15MM MODULAR FEMORAL HEAD?

PCA +15MM MODULAR FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 1996-01-18. The listed applicant is Howmedica Corp.. The 510(k) number is K955305.

When did PCA +15MM MODULAR FEMORAL HEAD receive FDA 510(k) clearance?

PCA +15MM MODULAR FEMORAL HEAD received FDA 510(k) clearance on 1996-01-18, under 510(k) number K955305.

Who is the listed applicant for PCA +15MM MODULAR FEMORAL HEAD?

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 PCA +15MM MODULAR FEMORAL HEAD?

The FDA product code for PCA +15MM MODULAR FEMORAL HEAD is MEH.

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Other records listing Howmedica Corp. as applicant

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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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