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FDA 510(k)

APTUS Hand System; APTUS Elbow Dorsal Olecranon

K-Number: K243610 · 2025-03-07

ApplicantMedartis AG
Decision Date2025-03-07
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS Hand System; APTUS Elbow Dorsal Olecranon is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2025-03-07 under approval number K243610. 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 Hand System; APTUS Elbow Dorsal Olecranon?

APTUS Hand System; APTUS Elbow Dorsal Olecranon is a medical device that received FDA 510(k) clearance on 2025-03-07. It is manufactured by Medartis AG. The 510(k) number is K243610.

When was APTUS Hand System; APTUS Elbow Dorsal Olecranon approved by the FDA?

APTUS Hand System; APTUS Elbow Dorsal Olecranon received FDA 510(k) clearance on 2025-03-07, under approval number K243610.

What company makes APTUS Hand System; APTUS Elbow Dorsal Olecranon?

APTUS Hand System; APTUS Elbow Dorsal Olecranon is manufactured by Medartis AG.

What is the FDA product code for APTUS Hand System; APTUS Elbow Dorsal Olecranon?

The FDA product code for APTUS Hand System; APTUS Elbow Dorsal Olecranon is 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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