FDA 510(k)

COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS

K-Number: K003566 · 2001-02-14

Decision Date2001-02-14

Product CodeKWS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2001-02-14 under 510(k) number K003566. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS?

COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K003566.

When did COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS receive FDA 510(k) clearance?

COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS received FDA 510(k) clearance on 2001-02-14, under 510(k) number K003566.

Who is the listed applicant for COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS?

The FDA product code for COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS is KWS.

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Related Devices (Code: KWS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.