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FDA 510(k)

Sterile Products of the APTUS System

K-Number: K232144 · 2023-08-18

ApplicantMedartis AG
Decision Date2023-08-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sterile Products of the APTUS 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 2023-08-18 under 510(k) number K232144. 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 Sterile Products of the APTUS System?

Sterile Products of the APTUS System is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Medartis AG. The 510(k) number is K232144.

When did Sterile Products of the APTUS System receive FDA 510(k) clearance?

Sterile Products of the APTUS System received FDA 510(k) clearance on 2023-08-18, under 510(k) number K232144.

Who is the listed applicant for Sterile Products of the APTUS 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 Sterile Products of the APTUS System?

The FDA product code for Sterile Products of the APTUS System is HRS.

Other records listing Medartis AG as applicant

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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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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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