FDA 510(k)

Genostis Osteosynthesis System

K-Number: K242988 · 2025-06-27

Decision Date2025-06-27

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Genostis Osteosynthesis System is a medical device manufactured by Genostis AF. It received FDA 510(k) clearance on 2025-06-27 under approval 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. It is manufactured by Genostis AF. The 510(k) number is K242988.

When was Genostis Osteosynthesis System approved by the FDA?

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

What company makes Genostis Osteosynthesis System?

Genostis Osteosynthesis System is manufactured by Genostis AF.

What is the FDA product code for Genostis Osteosynthesis System?

The FDA product code for Genostis Osteosynthesis System 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.