FDA 510(k)

SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW

K-Number: K040542 · 2004-08-19

Decision Date2004-08-19

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW 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 2004-08-19 under 510(k) number K040542. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW?

SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW is a medical device that received FDA 510(k) clearance on 2004-08-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K040542.

When did SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW receive FDA 510(k) clearance?

SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW received FDA 510(k) clearance on 2004-08-19, under 510(k) number K040542.

Who is the listed applicant for SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW?

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 SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW?

The FDA product code for SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW is HWC. This falls under the Cardiovascular category.

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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.