Identity
- Trade Name
- iFuse Granite Implant System FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated FDA UDI
- Device Name
- 10.5 mm x 95 mm iFuse Bedrock Granite Implant FDA UDI
- Model / Reference
- 105095BG FDA UDI
- Description
- 10.5 mm x 95 mm iFuse Bedrock Granite Implant FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055521418 FDA UDI
- 510(k) Number
- K220195 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
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
- Length — 95 Millimeter FDA UDIOuter Diameter — 10.5 Millimeter FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implant, coated
The iFuse Granite Implant System is a proprietary orthopedic implant designed to provide temporary stabilization and encourage long-term joint fusion in patients suffering from sacroiliac joint pain. Made of metal with a porous plasma spray coating, this implant features a unique cross-sectional design that allows for optimal fixation and durability.
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
Cleared under the same submission
K220195 also covers:
- iFuse Bedrock Granite Implant System — Si-Bone Inc.
- iFuse Bedrock Granite Implant System — Si-Bone Inc.
- iFuse Bedrock Granite Implant System — Si-Bone Inc.
- iFuse Bedrock Granite Implant System — Si-Bone Inc.
- iFuse Bedrock Granite Implant System — Si-Bone Inc.
- iFuse Granite Implant System — Si-Bone Inc.
- iFuse Granite Implant System — Si-Bone Inc.
- iFuse Granite Implant System — Si-Bone Inc.
- iFuse Granite Implant System — Si-Bone Inc.
- iFuse Granite Implant System — Si-Bone Inc.
- iFuse Granite Implant System — Si-Bone Inc.
- iFuse Granite Implant System — Si-Bone Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Si-Bone Inc.
Sources (1)
- FDA UDI 60ff6b70-ae02-4643-a013-b540ba6861b9 36 fields · synced Jul 11, 2026