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FDA 510(k)

APTUS FOOT SYSTEM

K-Number: K091479 · 2009-07-13

ApplicantMedartis AG
Decision Date2009-07-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS FOOT 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 2009-07-13 under 510(k) number K091479. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTUS FOOT SYSTEM?

APTUS FOOT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-13. The listed applicant is Medartis AG. The 510(k) number is K091479.

When did APTUS FOOT SYSTEM receive FDA 510(k) clearance?

APTUS FOOT SYSTEM received FDA 510(k) clearance on 2009-07-13, under 510(k) number K091479.

Who is the listed applicant for APTUS FOOT 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 FOOT SYSTEM?

The FDA product code for APTUS FOOT SYSTEM is HRS.

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Related Devices (Code: HRS)

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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