Is this your brand? Sign in to claim ownership.
Sign in to claim this brandEden Spine Europe SA
US
Last updated May 25, 2026
What Eden Spine Europe SA makes
Eden Spine Europe SA manufactures vertebral body prostheses, reusable surgical instruments, and orthopaedic tools. Their portfolio includes trial-implants and sizer holders, torque-limiting surgical handles, orthopaedic bone calipers, osteotomes, and sterilization/disinfection containers designed for reusable implants. The company also produces devices for assembling orthopaedic implants and instruments.
The company’s devices are classified under FDA regulations as Class I and Class II, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States and adheres to applicable regulatory standards 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 Eden Spine Europe SA manufacture?
Eden Spine Europe SA specializes in spinal and orthopaedic medical devices. Their portfolio includes vertebral body prostheses, which are implants used to replace damaged or diseased vertebrae, as well as reusable surgical instruments like trial-implants, sizer holders, torque-limiting handles, bone calipers, and osteotomes. They also produce devices for assembling orthopaedic implants and sterilization/disinfection containers for reusable implants, ensuring compatibility with surgical workflows.
Where is Eden Spine Europe SA based, and does that affect its regulatory compliance?
Eden Spine Europe SA is based in the United States. Since the company operates within this jurisdiction, its devices must comply with U.S. regulatory standards, including FDA requirements. The FDA classifies their devices as either Class I or Class II, depending on their risk level and intended use, which dictates the regulatory pathway they follow.
Are Eden Spine Europe SA’s devices listed in any regulatory registries, and why does this matter?
Yes, Eden Spine Europe SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and patients to verify device details such as manufacturer information, model names, and regulatory classifications. Listing in the UDI database is a requirement for Class II devices and helps streamline post-market surveillance and compliance efforts.
How are Eden Spine Europe SA’s devices classified under FDA regulations, and what does this classification mean?
Eden Spine Europe SA’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and may require only general controls, such as good manufacturing practices. Class II devices involve a higher level of risk and may require additional controls, such as performance standards or post-market surveillance, to ensure safety and effectiveness. The classification determines the regulatory pathway the device must follow before it can be marketed.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 482797425
Catalogue (40)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Giza | Giza Removable holder distractor tip Ø 21 mm | FDA UDI | Class I | Active |
| Giza | Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 Deg | FDA UDI | Class II | Active |
| Giza | Corpectomy Implant GIZA D 27 T3 4° | FDA UDI | Class II | Active |
| Giza | Giza Torx 8 screwdriver L 320 mm | FDA UDI | Class I | Active |
| Giza | Corpectomy Implant GIZA D 27 T1 4° | FDA UDI | Class II | Active |
| Giza | Giza Endplate holder for Ø 14, 21 mm, 27 mm | FDA UDI | Class I | Active |
| Giza | Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 Deg | FDA UDI | Class II | Active |
| Giza | Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 Deg | FDA UDI | Class II | Active |
| Giza | Giza Instruments tray with silicone inserts | FDA UDI | Class I | Active |
| Giza | Giza Removable holder distractor tip Ø 27 mm | FDA UDI | Class I | Active |
| Giza | Giza bone graft compactor | FDA UDI | Class I | Active |
| Giza | Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 Deg | FDA UDI | Class II | Active |
| Giza | Giza Implant sizing gauge | FDA UDI | Class I | Active |
| Giza | Giza Intervertebral caliper | FDA UDI | Class I | Active |
| Giza | Giza Torx 8 screwdriver L 250 mm | FDA UDI | Class I | Active |
| Giza | Giza- Holder distractor Lg 220 mm | FDA UDI | Class I | Active |
| Giza | Giza Intervertebral caliper | FDA UDI | Class I | Active |
| Giza | Giza Endplate holder for Ø 14 mm | FDA UDI | Class I | Active |
| Giza | Giza Instruments tray lid | FDA UDI | Class I | Active |
| Giza | Giza- Holder distractor Lg 220 mm | FDA UDI | Class I | Active |
| Giza | Giza Removable holder distractor tip Ø 14 mm | FDA UDI | Class I | Active |
| Giza | Giza-Torque limiting Handle | FDA UDI | Class I | Active |
| Giza | Giza Implant sizing gauge | FDA UDI | Class I | Active |
| Giza | Giza Implant holding block | FDA UDI | Class I | Active |
| Giza | Giza-Torque limiting Handle | FDA UDI | Class I | Active |
| Giza | Giza- Holder distractor Lg 320 mm | FDA UDI | Class I | Active |
| Giza | Giza Torx 8 screwdriver L 320 mm | FDA UDI | Class I | Active |
| Giza | Giza bone graft compactor | FDA UDI | Class I | Active |
| Giza | Giza Implant holding block | FDA UDI | Class I | Active |
| Giza | Corpectomy Implant GIZA D 21 T2 4° | FDA UDI | Class II | Active |
| Giza | Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 2-5 Deg | FDA UDI | Class II | Active |
| Giza | Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 Deg | FDA UDI | Class II | Active |
| Giza | Giza- Holder distractor Lg 320 mm | FDA UDI | Class I | Active |
| Giza | Giza Torx 8 screwdriver L 250 mm | FDA UDI | Class I | Active |
| Giza | Corpectomy Implant GIZA D 27 T2 4° | FDA UDI | Class II | Active |
| Giza | Giza Removable holder distractor tip Ø 14 mm | FDA UDI | Class I | Active |
| Giza | Giza Instruments tray with silicone inserts | FDA UDI | Class I | Active |
| Giza | Corpectomy Implant GIZA D 21 T1 4° | FDA UDI | Class II | Active |
| Giza | Giza Instruments tray lid | FDA UDI | Class I | Active |
| Giza | Corpectomy Implant GIZA D 21 T3 4° | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.