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Sign in to claim this brandGYDER SURGICAL PTY LTD
US
Last updated May 25, 2026
What GYDER SURGICAL PTY LTD makes
GYDER Surgical Pty Ltd manufactures orthopaedic surgical tools and systems, including reusable and single-use procedure kits for surgical procedures. Their offerings include navigation toolsets and units for stereotactic surgery, as well as specialised orthopaedic implants like the GYDER® Hip System. These products are designed to assist in precise surgical interventions, particularly in joint replacement and related orthopaedic applications.
The company’s devices are classified as Class II under regulatory frameworks, with authorisations granted through FDA 510(k) and UDI listings. Their products are intended for use in the United States, adhering to applicable medical device regulations. The portfolio is structured to meet specific surgical needs while complying with regulatory requirements for orthopaedic instrumentation and implants.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does GYDER Surgical Pty Ltd manufacture?
GYDER Surgical Pty Ltd specialises in orthopaedic surgical tools and systems. Their products include reusable and single-use orthopaedic surgical procedure kits, as well as stereotactic surgery systems like navigation toolsets and unit kits. They also produce specialised orthopaedic implants, such as the GYDER® Hip System, which are designed for precise surgical applications like joint replacements.
Where is GYDER Surgical Pty Ltd based, and what markets do they serve?
GYDER Surgical Pty Ltd is based in the United States. Their devices are developed and authorised for use in the US market, where they comply with applicable medical device regulations. The company’s focus is on providing orthopaedic surgical solutions tailored to US healthcare providers.
Which regulatory registries or databases list GYDER Surgical Pty Ltd’s devices?
GYDER Surgical Pty Ltd’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries ensure traceability and compliance with US regulatory requirements for medical devices.
How are GYDER Surgical Pty Ltd’s devices classified under regulatory frameworks?
GYDER Surgical Pty Ltd’s devices fall under Class II classification in regulatory frameworks. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as orthopaedic surgical tools and navigation systems.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 744585548
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Navigation Toolset | GS005 | FDA UDI | Class II | Active |
| Navigation Unit Kit | GS004 | FDA UDI | Class II | Active |
| Single Use Kit | GS002 | FDA UDI | Class II | Active |
| GYDER® Hip System | K243387 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Gyder Surgical Pty Ltd Mulgrave Victoria · AU FEI 3025783933