FDA 510(k)

ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT

K-Number: K061665 · 2006-07-25

Decision Date2006-07-25

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2006-07-25 under 510(k) number K061665. 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 ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT?

ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT is a medical device that received FDA 510(k) clearance on 2006-07-25. The listed applicant is Arthrex, Inc.. The 510(k) number is K061665.

When did ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT receive FDA 510(k) clearance?

ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT received FDA 510(k) clearance on 2006-07-25, under 510(k) number K061665.

Who is the listed applicant for ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT?

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

What is the FDA product code for ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT?

The FDA product code for ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT 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.