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FDA 510(k)

Genostis Osteosynthesis System

K-Number: K242988 · 2025-06-27

ApplicantGenostis AF
Decision Date2025-06-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genostis Osteosynthesis System is the device name listed in this FDA 510(k) record. The listed applicant is Genostis AF. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K242988. 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 Genostis Osteosynthesis System?

Genostis Osteosynthesis System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Genostis AF. The 510(k) number is K242988.

When did Genostis Osteosynthesis System receive FDA 510(k) clearance?

Genostis Osteosynthesis System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K242988.

Who is the listed applicant for Genostis Osteosynthesis System?

The FDA 510(k) record lists Genostis AF as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Genostis Osteosynthesis System?

The FDA product code for Genostis Osteosynthesis System is HRS.

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

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

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