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US
Last updated May 30, 2026
What Onefit Medical makes
Onefit Medical makes orthopaedic and craniofacial implantation planning software, including products such as spineEOS, hipEOS, and kneeEOS, which are used for planning implantations. These software products are designed to assist with planning and placement of implants in the spine, hip, and knee. The company's products are examples of orthopaedic/craniofacial implantation planning software.
The company's portfolio is regulated as Class II devices and is listed in the FDA's 510k and UDI registries. Onefit Medical is based in the US. The company's devices are subject to regulatory oversight and are listed in publicly accessible registries.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of products does Onefit Medical make?
Onefit Medical makes orthopaedic and craniofacial implantation planning software, such as spineEOS and hipEOS, to assist with planning and placement of implants.
Where is Onefit Medical based?
Onefit Medical is based in the US, and its products are listed in US regulatory registries.
Which registries list Onefit Medical's devices?
Onefit Medical's devices are listed in the FDA's 510k and UDI registries, which are publicly accessible.
How are Onefit Medical's devices classified?
Onefit Medical's devices are classified as Class II devices, subject to regulatory oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- onefit-medical.com
- —
- —
- [email protected]
- Phone
- +33381252427
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 263373588
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| spineEOS rod Template | KIT0706 | FDA UDI | Class I | Unknown |
| spineEOS rod Template | KIT0703 | FDA UDI | Class I | Unknown |
| spineEOS | 1.1 | FDA UDI | Class II | Unknown |
| spineEOS | 1.x | FDA UDI | Class II | Active |
| spineEOS rod Template | KIT0705 | FDA UDI | Class I | Unknown |
| hipEOS | 2.5 | FDA UDI | Class II | Unknown |
| spineEOS rod Template | KIT0708 | FDA UDI | Class I | Unknown |
| spineEOS rod Template | KIT0701 | FDA UDI | Class I | Unknown |
| spineEOS rod Template | KIT0707 | FDA UDI | Class I | Unknown |
| kneeEOS | 1.0 | FDA UDI | Class II | Unknown |
| hipEOS | 3.x | FDA UDI | Class II | Active |
| hipEOS | 2.x | FDA UDI | Class II | Unknown |
| spineEOS rod Template | KIT0702 | FDA UDI | Class I | Unknown |
| spineEOS rod Template | KIT0704 | FDA UDI | Class I | Unknown |
| Onefit Hip Planner | K142671 | FDA 510(k) | Class II | Active |
| hipEOS | K161479 | FDA 510(k) | Class II | Active |
| kneeEOS | K161828 | FDA 510(k) | Class II | Active |
| hipEOS | K173390 | FDA 510(k) | Class II | Active |
| spineEOS | K160407 | FDA 510(k) | Class II | Active |
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