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Sign in to claim this brandOrthodoxo LLC
US
Last updated May 27, 2026
What Orthodoxo LLC makes
Orthodoxo LLC manufactures single-use arthroscopic shaver system blades designed for surgical procedures. These blades are intended for use in arthroscopic surgeries to remove tissue or debris from joint spaces, such as the knee or shoulder.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer 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 Orthodoxo LLC manufacture?
Orthodoxo LLC specializes in single-use arthroscopic shaver system blades. These devices are specifically designed for surgical use in arthroscopic procedures, where they help remove tissue or debris from joint spaces like the knee or shoulder. The company’s focus is on this one category of Class I medical devices.
Where is Orthodoxo LLC based?
Orthodoxo LLC is headquartered in the United States. The company’s location is relevant for understanding its regulatory context, as it operates under U.S. medical device regulations.
How are Orthodoxo LLC’s devices classified by regulatory authorities?
Orthodoxo LLC’s arthroscopic shaver system blades are classified as Class I medical devices under FDA regulations. This classification is typically assigned to devices posing the lowest risk, often involving minimal or non-invasive procedures. The classification helps determine regulatory oversight requirements.
Are Orthodoxo LLC’s devices listed in any regulatory registries?
Yes, Orthodoxo LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to verify device details like manufacturer information and regulatory status.
Why are Orthodoxo LLC’s devices classified as Class I?
Orthodoxo LLC’s arthroscopic shaver blades are classified as Class I because they are intended for low-risk, non-invasive use in surgical procedures. Class I devices generally involve minimal risk to patients, such as single-use tools with straightforward functions like tissue removal in arthroscopic surgeries. This classification aligns with their design and intended use.
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
- 119341314
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Arthrorazor | 2077.02302 | FDA UDI | Class I | Active |
| Arthrorazor | 2077.01304 | FDA UDI | Class I | Active |
| ArthroRazor | 2077.02251 | FDA UDI | Class I | Active |
| Arthrorazor | 2077.01424 | FDA UDI | Class I | Active |
| Arthrorazor | 2077.01202 | FDA UDI | Class I | Active |
| Arthrorazor | 2077.02301 | FDA UDI | Class I | Active |
| ArthroRazor | 2077.01421 | FDA UDI | Class I | Active |
| Arthrorazor | 2077.02421 | FDA UDI | Class I | Active |
| Arthrorazor | 2077.01251 | FDA UDI | Class I | Active |
| Arthrorazor | 2077.01423 | FDA UDI | Class I | Active |
| Arthrorazor | 2077.01302 | FDA UDI | Class I | Active |
| Arthrorazor | 2077.02422 | FDA UDI | Class I | Active |
| Arthrorazor | 2077.01422 | FDA UDI | Class I | Active |
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