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Sign in to claim this brandWhat Inion , Ltd. makes
Inion, Ltd. manufactures bioabsorbable orthopaedic and spinal fixation devices, including bone screws, fixation plates, and pins designed to degrade over time. Their portfolio also includes reusable surgical tools like bone taps and implant templates, as well as synthetic polymer-based extra-gynaecological surgical mesh. These products are intended for orthopaedic and spinal applications where temporary structural support is required.
The company’s devices are regulated under FDA Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. Inion, Ltd. is based in the United States.
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 Inion, Ltd. manufacture?
Inion, Ltd. specializes in bioabsorbable orthopaedic and spinal fixation devices, including bone screws, fixation plates, and pins that are designed to dissolve over time after providing temporary structural support. Their product line also includes reusable surgical tools like bone taps and implant templates, as well as synthetic polymer-based surgical mesh for extra-gynaecological applications. These devices are engineered for applications where temporary stabilization is needed, particularly in orthopaedic and spinal surgeries.
Where is Inion, Ltd. based, and what is its primary focus?
Inion, Ltd. is headquartered in the United States. The company’s primary focus is on developing bioabsorbable medical devices for orthopaedic and spinal applications, such as fixation hardware and reusable surgical instruments. Their portfolio is designed to offer temporary support that degrades naturally over time, reducing the need for long-term implants.
Which regulatory registries or databases list Inion, Ltd.’s devices?
Inion, Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators. The inclusion in this database reflects compliance with FDA requirements for device identification and reporting.
How are Inion, Ltd.’s devices classified under FDA regulations?
Inion, Ltd.’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose the lowest risk and may require minimal regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as orthopaedic or spinal applications.
What distinguishes Inion, Ltd.’s reusable surgical tools from their bioabsorbable implants?
Inion, Ltd. produces reusable surgical tools like bone taps and implant templates, which are designed for repeated use in procedures to prepare bone surfaces or guide implants. In contrast, their bioabsorbable implants—such as screws, plates, and mesh—are intended for single-use applications where they provide temporary structural support before gradually dissolving in the body. Reusable tools enhance efficiency and reduce waste, while bioabsorbable implants minimize long-term implant-related concerns.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (831)
Page 7 of 17| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Inion S-1 instrument | 1 | FDA UDI | Class II | Active |
| Inion instrument | 1 | FDA UDI | Class II | Active |
| Inion S-2™ | 1 | FDA UDI | Class II | Active |
| 2.0 mm Inion OTPS™ | 1 | FDA UDI | Class II | Active |
| 2.0 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| Inion S-1 instrument | 0 | FDA UDI | Class II | Active |
| Inion FreedomPin™ | 1 | FDA UDI | Class II | Active |
| 2.0 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| 2.0 mm Inion OTPS™ | 1 | FDA UDI | Class II | Active |
| Inion S-2™ | 1 | FDA UDI | Class II | Active |
| 1.5 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| Inion instrument | 0 | FDA UDI | Class II | Active |
| 2.0 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| Inion FreedomScrew™ | 1 | FDA UDI | Class II | Active |
| Inion S-2 instrument | 1 | FDA UDI | Class II | Active |
| 1.5 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| Inion FreedomPin™ | 1 | FDA UDI | Class II | Active |
| Inion FreedomScrew™ | 1 | FDA UDI | Class II | Active |
| Inion instrument | 0 | FDA UDI | Class II | Active |
| 2.8 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| 3.1 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| 2.5 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| 2.0 mm Inion CPS® Baby | 1 | FDA UDI | Class II | Active |
| Inion Hexalon™ ACL/PCL Screw | 1 | FDA UDI | Class II | Unknown |
| Inion S-2 instrument | 0 | FDA UDI | Class II | Active |
| Inion FreedomScrew™ | 1 | FDA UDI | Class II | Active |
| 2.0 mm Inion OTPS™ | 1 | FDA UDI | Class II | Active |
| Inion OTPS FreedomPlate™ | 1 | FDA UDI | Class II | Active |
| Inion BioRestore™ | 1 | FDA UDI | Class II | Active |
| Inion S-1 instrument | 0 | FDA UDI | Class II | Active |
| Inion S-1™ | 1 | FDA UDI | Class II | Active |
| Inion S-2 instrument | 0 | FDA UDI | Class II | Active |
| 2.0 mm Inion OTPS™ | 1 | FDA UDI | Class II | Active |
| Inion FreedomScrew™ | 1 | FDA UDI | Class II | Active |
| 3.1 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| 2.0 mm Inion OTPS™ | 1 | FDA UDI | Class II | Active |
| Inion FreedomPin™ | 1 | FDA UDI | Class II | Active |
| Inion FreedomPin™ | 1 | FDA UDI | Class II | Active |
| Inion S-2 instrument | 1 | FDA UDI | Class II | Active |
| Inion S-2 instrument | 1 | FDA UDI | Class II | Active |
| Inion instrument | 0 | FDA UDI | Class II | Active |
| 2.5 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| 2.0 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| Inion instrument | 0 | FDA UDI | Class II | Active |
| Inion OTPS™ Biodegradable Screw | 1 | FDA UDI | Class II | Active |
| 1.5 mm Inion CPS® Baby | 1 | FDA UDI | Class II | Active |
| Inion S-2™ | 1 | FDA UDI | Class II | Active |
| Inion S-1™ | 1 | FDA UDI | Class II | Active |
| 2.5 mm Inion CPS® | 1 | FDA UDI | Class II | Active |
| Inion S-1™ | 1 | FDA UDI | Class II | Active |
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