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FDA 510(k)

HUMERAL STAPLE

K-Number: K041355 · 2004-07-30

ApplicantSmith & Nephew, Inc.
Decision Date2004-07-30
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HUMERAL STAPLE 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 2004-07-30 under 510(k) number K041355. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMERAL STAPLE?

HUMERAL STAPLE is a medical device that received FDA 510(k) clearance on 2004-07-30. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K041355.

When did HUMERAL STAPLE receive FDA 510(k) clearance?

HUMERAL STAPLE received FDA 510(k) clearance on 2004-07-30, under 510(k) number K041355.

Who is the listed applicant for HUMERAL STAPLE?

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 HUMERAL STAPLE?

The FDA product code for HUMERAL STAPLE is HTY.

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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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