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FDA 510(k)

APTUS Hand Scaphoid Plates

K-Number: K234062 · 2024-03-21

ApplicantMedartis AG
Decision Date2024-03-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS Hand Scaphoid Plates is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2024-03-21 under approval number K234062. 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 Scaphoid Plates?

APTUS Hand Scaphoid Plates is a medical device that received FDA 510(k) clearance on 2024-03-21. It is manufactured by Medartis AG. The 510(k) number is K234062.

When was APTUS Hand Scaphoid Plates approved by the FDA?

APTUS Hand Scaphoid Plates received FDA 510(k) clearance on 2024-03-21, under approval number K234062.

What company makes APTUS Hand Scaphoid Plates?

APTUS Hand Scaphoid Plates is manufactured by Medartis AG.

What is the FDA product code for APTUS Hand Scaphoid Plates?

The FDA product code for APTUS Hand Scaphoid Plates is HRS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.