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FDA 510(k)

DARCO HEADED CANNULATED SCREW

K-Number: K100359 · 2010-06-24

ApplicantWrightmedicaltechnologyinc
Decision Date2010-06-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DARCO HEADED CANNULATED SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2010-06-24 under 510(k) number K100359. 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 DARCO HEADED CANNULATED SCREW?

DARCO HEADED CANNULATED SCREW is a medical device that received FDA 510(k) clearance on 2010-06-24. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K100359.

When did DARCO HEADED CANNULATED SCREW receive FDA 510(k) clearance?

DARCO HEADED CANNULATED SCREW received FDA 510(k) clearance on 2010-06-24, under 510(k) number K100359.

Who is the listed applicant for DARCO HEADED CANNULATED SCREW?

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

What is the FDA product code for DARCO HEADED CANNULATED SCREW?

The FDA product code for DARCO HEADED CANNULATED SCREW is HWC. This falls under the Cardiovascular category.

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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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