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FDA 510(k)

GYDER® Hip System

K-Number: K243387 · 2025-01-29

ApplicantGyder Surgical Pty, Ltd.
Decision Date2025-01-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GYDER® Hip System is a medical device manufactured by Gyder Surgical Pty, Ltd.. It received FDA 510(k) clearance on 2025-01-29 under approval number K243387. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYDER® Hip System?

GYDER® Hip System is a medical device that received FDA 510(k) clearance on 2025-01-29. It is manufactured by Gyder Surgical Pty, Ltd.. The 510(k) number is K243387.

When was GYDER® Hip System approved by the FDA?

GYDER® Hip System received FDA 510(k) clearance on 2025-01-29, under approval number K243387.

What company makes GYDER® Hip System?

GYDER® Hip System is manufactured by Gyder Surgical Pty, Ltd..

What is the FDA product code for GYDER® Hip System?

The FDA product code for GYDER® Hip System is OLO.

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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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