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FDA 510(k)

MODULAR UNIPOLAR SYSTEM

K-Number: K902365 · 1991-01-11

ApplicantHowmedica Corp.
Decision Date1991-01-11
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODULAR UNIPOLAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1991-01-11 under 510(k) number K902365. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODULAR UNIPOLAR SYSTEM?

MODULAR UNIPOLAR SYSTEM is a medical device that received FDA 510(k) clearance on 1991-01-11. The listed applicant is Howmedica Corp.. The 510(k) number is K902365.

When did MODULAR UNIPOLAR SYSTEM receive FDA 510(k) clearance?

MODULAR UNIPOLAR SYSTEM received FDA 510(k) clearance on 1991-01-11, under 510(k) number K902365.

Who is the listed applicant for MODULAR UNIPOLAR SYSTEM?

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 MODULAR UNIPOLAR SYSTEM?

The FDA product code for MODULAR UNIPOLAR SYSTEM is KWL.

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Other records listing Howmedica Corp. as applicant

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Related Devices (Code: KWL)

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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