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7.5mm and 10.75mm iFuse Implant System Instrument Set (No Disposables) Tray Syst
FDA UDIEUDAMEDClass I (US FDA UDI)
by Si-Bone Inc.
Identity
- Trade Name
- 7.5mm and 10.75mm iFuse Implant System Instrument Set (No Disposables) Tray Syst FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
- Device Name
- 7.5mm and 10.75mm iFuse Implant System Instrument Set (No Disposables) Tray System FDA UDI
- Model / Reference
- 400505 FDA UDI
- Description
- 7.5mm and 10.75mm iFuse Implant System Instrument Set (No Disposables) Tray System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055525904 FDA UDI
- FDA Product Code
- OJH FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implantation kit
7.5mm and 10.75mm iFuse Implant System Instrument Set (No Disposables) Tray Syst by Si-Bone Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Si-Bone Inc.
Sources (2)
- FDA UDI f23d1e3a-2641-437a-8414-de53a85bfeae 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026