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Sign in to claim this brandFIELD ORTHOPAEDICS PTY LTD
US
Last updated May 23, 2026
What FIELD ORTHOPAEDICS PTY LTD makes
Field Orthopaedics produces orthopaedic fixation devices, including non-bioabsorbable bone screws (both sterile and non-sterile) and bone pins for internal fixation. Their portfolio also covers reusable surgical instruments such as drill guides, screwdrivers, depth gauges, and instrument trays, alongside single-use cannulated drill bits for orthopaedic procedures. The company’s nail and screw systems are designed for fracture stabilization and bone alignment in orthopaedic surgery.
The devices are classified under FDA regulations as Class I and Class II, with most listed in the FDA’s Unique Device Identifier (UDI) database. Field Orthopaedics operates from the United States, adhering to domestic regulatory requirements for medical devices in that jurisdiction.
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 Field Orthopaedics Pty Ltd manufacture?
Field Orthopaedics Pty Ltd specializes in orthopaedic fixation devices, primarily focusing on non-bioabsorbable bone screws (both sterile and non-sterile) and bone pins. Their product range also includes reusable surgical instruments like drill guides, screwdrivers, depth gauges, and instrument trays, as well as single-use cannulated surgical drill bits. These devices are designed for fracture stabilization, bone alignment, and internal fixation in orthopaedic surgery.
Where is Field Orthopaedics Pty Ltd based, and does it operate under specific regulatory requirements?
Field Orthopaedics Pty Ltd is based in the United States. Since it operates domestically, its devices must comply with the FDA’s regulatory requirements, including classification under FDA regulations as Class I or Class II, and many of its devices are listed in the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries or databases list Field Orthopaedics’ devices?
Field Orthopaedics’ devices are primarily listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.
How are Field Orthopaedics’ devices classified under FDA regulations?
Field Orthopaedics’ devices are classified under the FDA’s regulatory framework as either Class I or Class II. Class I devices generally pose minimal risk and may require less stringent controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.
What distinguishes Field Orthopaedics’ orthopaedic fixation devices from others in the market?
Field Orthopaedics’ devices are tailored for orthopaedic procedures, including fracture stabilization and bone alignment, with a focus on non-bioabsorbable materials for durability. Their portfolio includes both implantable components (like screws and pins) and reusable surgical tools (such as drill guides and screwdrivers), ensuring compatibility for various stages of orthopaedic surgery. The company’s systems, such as the FO NX Nail System and FO Micro Screw System, are designed to meet specific clinical needs in internal fixation.
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
- 744008914
Catalogue (351)
Page 1 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FO NX Nail System | APN000258 | FDA UDI | Class II | Active |
| FO Micro Screw System | MSCP-0715 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000907 | FDA UDI | Class I | Active |
| FO NX Nail System | APN000218 | FDA UDI | Class II | Active |
| FO NX Nail System | APN001328 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000211 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000210 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000013 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000225 | FDA UDI | Class II | Active |
| FO NX Nail System | APN001293 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000003 | FDA UDI | Class II | Active |
| FO NX Nail System | APN001320 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000213 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000269 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000261 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000069 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000277 | FDA UDI | Class I | Active |
| FO NX Nail System | APN001280 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000071 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000079 | FDA UDI | Class II | Active |
| FO Micro Screw System | MSCP-0920 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000043 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000072 | FDA UDI | Class II | Active |
| FO Micro Screw System | MSCP-1320 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000025 | FDA UDI | Class I | Active |
| FO NX Nail System | APN001285 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000906 | FDA UDI | Class I | Active |
| FO Micro Screw System | MSCP-1520 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000262 | FDA UDI | Class I | Active |
| FO NX Nail System | APN001279 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000250 | FDA UDI | Class I | Active |
| FO NX Nail System | APN000208 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000199 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000257 | FDA UDI | Class I | Active |
| FO Micro Screw System | CPN000005 | FDA UDI | Class II | Active |
| FO Micro Screw System | MSCP-1020 | FDA UDI | Class II | Active |
| FO NX Nail System | APN001317 | FDA UDI | Class II | Active |
| FO Micro Screw System | FOGS-0020 | FDA UDI | Class I | Active |
| FO NX Nail System | APN000193 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000028 | FDA UDI | Class I | Active |
| FO Micro Screw System | CPN000021 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000911 | FDA UDI | Class I | Active |
| FO NX Nail System | APN001307 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000270 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000204 | FDA UDI | Class II | Active |
| FO Micro Screw System | MSCP-0615 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000007 | FDA UDI | Class II | Active |
| FO NX Nail System | APN001319 | FDA UDI | Class II | Active |
| FO NX Nail System | APN000195 | FDA UDI | Class II | Active |
| FO Micro Screw System | CPN000002 | FDA UDI | Class II | Active |
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