FDA 510(k)

GYDER® Hip System

K-Number: K243387 · 2025-01-29

Decision Date2025-01-29

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation Centre K261205SPINEART Navigation Instrument SystemSpineart SA K262121Ion-L Navigated InstrumentsSurGenTec, LLC K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics K261852OTS HipOrtoma AB

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.