FDA 510(k)

GYDER® Hip System

Numéro K : K243387 · 2025-01-29

Date de décision2025-01-29

Code produitOLO

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

What is the GYDER® Hip System?

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

When did GYDER® Hip System receive FDA 510(k) clearance?

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

Who is the listed applicant for GYDER® Hip System?

The FDA 510(k) record lists Gyder Surgical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Essais cliniques associés

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Dispositifs connexes (Code : OLO)

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Source officielle

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