Identity
- Trade Name
- iFuse Implant System-Navigation – Broach – 7.0 mm FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Broach EUDAMEDNavigation, Broach 7.0 mm FDA UDI
- Model / Reference
- 400193 EUDAMEDFDA UDI
- Description
- Navigation, Broach 7.0 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851085007626 EUDAMEDFDA UDI
- Basic UDI-DI
- 081005552BroachN4 EUDAMED
- Direct Marketing DI
- 00851085007626 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- L091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 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
Broach 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 | 081005552BroachN4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SI-BONE, Inc.
- EUDAMED SRN
- US-MF-000028624
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED 97f87c2e-bd3e-4f5c-8cc2-0c394cb375a8 61 fields · synced Jun 20, 2026
- FDA UDI f3d99c0e-550f-48c6-8965-73e5982b862b 34 fields · synced May 30, 2026