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FDA 510(k)

APTUS® Ankle Trauma System 2.8/3.5

K-Number: K193633 · 2020-03-26

ApplicantMedartis AG
Decision Date2020-03-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS® Ankle Trauma System 2.8/3.5 is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2020-03-26 under approval number K193633. 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® Ankle Trauma System 2.8/3.5?

APTUS® Ankle Trauma System 2.8/3.5 is a medical device that received FDA 510(k) clearance on 2020-03-26. It is manufactured by Medartis AG. The 510(k) number is K193633.

When was APTUS® Ankle Trauma System 2.8/3.5 approved by the FDA?

APTUS® Ankle Trauma System 2.8/3.5 received FDA 510(k) clearance on 2020-03-26, under approval number K193633.

What company makes APTUS® Ankle Trauma System 2.8/3.5?

APTUS® Ankle Trauma System 2.8/3.5 is manufactured by Medartis AG.

What is the FDA product code for APTUS® Ankle Trauma System 2.8/3.5?

The FDA product code for APTUS® Ankle Trauma System 2.8/3.5 is HRS.

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Related Devices (Code: HRS)

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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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