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FDA 510(k)

AAP CANNULATED SCREWS

K-Number: K111316 · 2011-07-20

ApplicantAap Implantate AG
Decision Date2011-07-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AAP CANNULATED SCREWS 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 2011-07-20 under 510(k) number K111316. 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 SCREWS?

AAP CANNULATED SCREWS is a medical device that received FDA 510(k) clearance on 2011-07-20. The listed applicant is Aap Implantate AG. The 510(k) number is K111316.

When did AAP CANNULATED SCREWS receive FDA 510(k) clearance?

AAP CANNULATED SCREWS received FDA 510(k) clearance on 2011-07-20, under 510(k) number K111316.

Who is the listed applicant for AAP CANNULATED SCREWS?

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 SCREWS?

The FDA product code for AAP CANNULATED SCREWS 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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