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FDA 510(k)

AAP CANNULATED SCREW AND DARCO HEADED SCREW

K-Number: K080101 · 2008-03-25

ApplicantAap Implantate AG
Decision Date2008-03-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AAP CANNULATED SCREW AND DARCO HEADED SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Aap Implantate AG. It received FDA 510(k) clearance on 2008-03-25 under 510(k) number K080101. 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 AAP CANNULATED SCREW AND DARCO HEADED SCREW?

AAP CANNULATED SCREW AND DARCO HEADED SCREW is a medical device that received FDA 510(k) clearance on 2008-03-25. The listed applicant is Aap Implantate AG. The 510(k) number is K080101.

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

AAP CANNULATED SCREW AND DARCO HEADED SCREW received FDA 510(k) clearance on 2008-03-25, under 510(k) number K080101.

Who is the listed applicant for AAP CANNULATED SCREW AND DARCO HEADED SCREW?

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

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

The FDA product code for AAP CANNULATED SCREW AND DARCO HEADED 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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