TITAN Nail; APTUS K-Wire System
K-Number: K260934 · 2026-04-17
ApplicantMedartis AG
Decision Date2026-04-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TITAN Nail; APTUS K-Wire System is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2026-04-17 under approval number K260934. 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 TITAN Nail; APTUS K-Wire System?
TITAN Nail; APTUS K-Wire System is a medical device that received FDA 510(k) clearance on 2026-04-17. It is manufactured by Medartis AG. The 510(k) number is K260934.
When was TITAN Nail; APTUS K-Wire System approved by the FDA?
TITAN Nail; APTUS K-Wire System received FDA 510(k) clearance on 2026-04-17, under approval number K260934.
What company makes TITAN Nail; APTUS K-Wire System?
TITAN Nail; APTUS K-Wire System is manufactured by Medartis AG.
What is the FDA product code for TITAN Nail; APTUS K-Wire System?
The FDA product code for TITAN Nail; 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.