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FDA 510(k)

APTUS K-WIRE SYSTEM

K-Number: K092038 · 2009-09-23

ApplicantMedartis AG
Decision Date2009-09-23
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS K-WIRE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2009-09-23 under 510(k) number K092038. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTUS K-WIRE SYSTEM?

APTUS K-WIRE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-23. The listed applicant is Medartis AG. The 510(k) number is K092038.

When did APTUS K-WIRE SYSTEM receive FDA 510(k) clearance?

APTUS K-WIRE SYSTEM received FDA 510(k) clearance on 2009-09-23, under 510(k) number K092038.

Who is the listed applicant for APTUS K-WIRE SYSTEM?

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 K-WIRE SYSTEM?

The FDA product code for APTUS K-WIRE SYSTEM is HTY.

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Other records listing Medartis AG as applicant

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Related Devices (Code: HTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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