Identity
- Trade Name
- iFuse Granite Implant System FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
- Device Name
- Bedrock Granite Dilator 3 FDA UDI
- Model / Reference
- 501235 FDA UDI
- Description
- Bedrock Granite Dilator 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055521043 FDA UDI
- 510(k) Number
- K220195 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
MR Conditional FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implantation kit
iFuse Granite Implant System by Si-Bone Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implantation kit.
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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
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Si-Bone Inc.
Sources (1)
- FDA UDI 13613fbc-dc77-47bb-9aa0-7100194bcb61 35 fields · synced May 31, 2026