FDA 510(k)

SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS

K-Number: K060736 · 2006-04-18

Decision Date2006-04-18

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS 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 2006-04-18 under 510(k) number K060736. 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 6.5MM AND 8.0MM CANNULATED SCREWS?

SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS is a medical device that received FDA 510(k) clearance on 2006-04-18. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K060736.

When did SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS receive FDA 510(k) clearance?

SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS received FDA 510(k) clearance on 2006-04-18, under 510(k) number K060736.

Who is the listed applicant for SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS?

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 6.5MM AND 8.0MM CANNULATED SCREWS?

The FDA product code for SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS 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.