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FDA 510(k)

DARCO HEADLESS COMPRESSION SCREW

K-Number: K080850 · 2008-04-10

ApplicantWrightmedicaltechnologyinc
Decision Date2008-04-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DARCO HEADLESS COMPRESSION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2008-04-10 under 510(k) number K080850. 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 HEADLESS COMPRESSION SCREW?

DARCO HEADLESS COMPRESSION SCREW is a medical device that received FDA 510(k) clearance on 2008-04-10. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K080850.

When did DARCO HEADLESS COMPRESSION SCREW receive FDA 510(k) clearance?

DARCO HEADLESS COMPRESSION SCREW received FDA 510(k) clearance on 2008-04-10, under 510(k) number K080850.

Who is the listed applicant for DARCO HEADLESS COMPRESSION 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 HEADLESS COMPRESSION SCREW?

The FDA product code for DARCO HEADLESS COMPRESSION 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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