Identity
- Trade Name
- iFuse TORQ Implant System FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
- Device Name
- Driver Sleeve Wrench EUDAMEDFDA UDI
- Model / Reference
- 400430 EUDAMEDFDA UDI
- Description
- Driver Sleeve Wrench FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055523665 EUDAMEDFDA UDI
- Basic UDI-DI
- 081005552WrenchWG EUDAMED
- Direct Marketing DI
- 00810055523665 EUDAMED
- 510(k) Number
- K203247 FDA UDI
- FDA Product Code
- OUR FDA UDILXH FDA UDI
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Conditional FDA UDI
Driver Sleeve Wrench by Si-Bone Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081005552WrenchWG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SI-BONE, Inc.
- EUDAMED SRN
- US-MF-000028624
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED a937b602-75d5-4347-adb2-39135ea6a7e9 61 fields · synced Jun 17, 2026
- FDA UDI e8fbe935-f490-4193-acb5-84bf98bce119 35 fields · synced May 30, 2026