FDA 510(k)

ASIAN INTRAMEDULLARY HIP SCREW NAILS

K-Number: K050226 · 2005-02-11

Decision Date2005-02-11

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ASIAN INTRAMEDULLARY HIP SCREW NAILS 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 2005-02-11 under 510(k) number K050226. 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 ASIAN INTRAMEDULLARY HIP SCREW NAILS?

ASIAN INTRAMEDULLARY HIP SCREW NAILS is a medical device that received FDA 510(k) clearance on 2005-02-11. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K050226.

When did ASIAN INTRAMEDULLARY HIP SCREW NAILS receive FDA 510(k) clearance?

ASIAN INTRAMEDULLARY HIP SCREW NAILS received FDA 510(k) clearance on 2005-02-11, under 510(k) number K050226.

Who is the listed applicant for ASIAN INTRAMEDULLARY HIP SCREW NAILS?

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 ASIAN INTRAMEDULLARY HIP SCREW NAILS?

The FDA product code for ASIAN INTRAMEDULLARY HIP SCREW NAILS 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.