Identity
- Trade Name
- iFuse Granite Implant System FDA UDI
- Generic Name
- Spinal bone set screw FDA UDI
- Device Name
- Bedrock Granite, Set Screw FDA UDI
- Model / Reference
- 501117 FDA UDI
- Description
- Bedrock Granite, Set Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055522088 FDA UDI
- 510(k) Number
- K220195 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Spinal bone set screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Spinal bone set screw
iFuse Granite Implant System by Si-Bone Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal bone set screw.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Si-Bone Inc.
Sources (1)
- FDA UDI d0807a73-2ac6-4b5f-a915-3f24e6cfb115 35 fields · synced Jun 8, 2026