iFuse Implant System
FDA UDIEUDAMEDClass II (US FDA UDI)
by Si-Bone Inc.
Identity
- Trade Name
- iFuse Implant System FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated FDA UDI
- Device Name
- iFuse implant EUDAMED
- Model / Reference
- 107530-90 EUDAMEDFDA UDI7565-90 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859256003910 EUDAMEDFDA UDI00859256003729 FDA UDI
- Basic UDI-DI
- 081005552ifuseimplantV9 EUDAMED
- FDA Product Code
- OUR FDA UDI
- EMDN Code
- P09070101 SPINAL CAGES EUDAMED
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 7.5 Millimeter FDA UDILength — 65 Millimeter FDA UDIOuter Diameter — 10.75 Millimeter FDA UDILength — 30 Millimeter FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implant, coated
iFuse Implant System by Si-Bone Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, coated.
- SImmetry Implant, 12.5mm x 100mm — Paradigm Spine, LLC · Class II
- SImmetry Implant, 14.5mm x 75mm — Paradigm Spine, LLC · Class II
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International · Class II
- BowTie SI Fusion System — SAIL FUSION · Class II
- SImmetry LAG Implant, 10.5mm x 105mm — Paradigm Spine, LLC · Class II
- SImmetry LAG Implant, 12.5mm x 90mm — Paradigm Spine, LLC · Class II
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International · Class II
- Silex Sacroiliac Joint Fusion System — Xtant Medical Holdings, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Si-Bone Inc.
Sources (3)
- FDA UDI 4993a65c-a8a8-4d9e-8d84-6d8c0bb0f7bb 34 fields · synced Jul 8, 2026
- FDA UDI c1c0b13d-21dd-4d57-b38b-ac9b7ab5ab22 34 fields · synced May 30, 2026
- EUDAMED e994aa8c-2873-4e15-9610-58a1cf8673cc 61 fields · synced Jul 8, 2026