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FDA 510(k)

APTUS CANNULATED COMPRESSION SCREWS

K-Number: K133460 · 2013-12-18

ApplicantMedartis AG
Decision Date2013-12-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS CANNULATED COMPRESSION SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2013-12-18 under 510(k) number K133460. 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 APTUS CANNULATED COMPRESSION SCREWS?

APTUS CANNULATED COMPRESSION SCREWS is a medical device that received FDA 510(k) clearance on 2013-12-18. The listed applicant is Medartis AG. The 510(k) number is K133460.

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

APTUS CANNULATED COMPRESSION SCREWS received FDA 510(k) clearance on 2013-12-18, under 510(k) number K133460.

Who is the listed applicant for APTUS CANNULATED COMPRESSION SCREWS?

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

What is the FDA product code for APTUS CANNULATED COMPRESSION SCREWS?

The FDA product code for APTUS CANNULATED COMPRESSION 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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