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FDA 510(k)

APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System

K-Number: K202589 · 2020-11-06

ApplicantMedartis AG
Decision Date2020-11-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2020-11-06 under approval number K202589. 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 headed Cannulated Compression Screws, APTUS K-Wire System?

APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System is a medical device that received FDA 510(k) clearance on 2020-11-06. It is manufactured by Medartis AG. The 510(k) number is K202589.

When was APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System approved by the FDA?

APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System received FDA 510(k) clearance on 2020-11-06, under approval number K202589.

What company makes APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System?

APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System is manufactured by Medartis AG.

What is the FDA product code for APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System?

The FDA product code for APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System 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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