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iFuse Bedrock Granite Implant System
FDA UDIClass II (US FDA UDI)
by Si-Bone Inc.
Identity
- Trade Name
- iFuse Bedrock Granite Implant System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- 9.5 mm x 75 mm iFuse Bedrock Granite Closed Head Implant FDA UDI
- Model / Reference
- 095075CH FDA UDI
- Description
- 9.5 mm x 75 mm iFuse Bedrock Granite Closed Head Implant FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055524020 FDA UDI
- 510(k) Number
- K233508 FDA UDI
- FDA Product Code
- OUR FDA UDINKB FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 9.5 Millimeter FDA UDILength — 75 Millimeter FDA UDI
Category: Spinal bone screw, non-bioabsorbableSacroiliac joint transarticular fixation/arthrodesis implant, coated
iFuse Bedrock Granite Implant System by Si-Bone Inc. — Class II — FDA UDI — listed in FDA GUDID — 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
Cleared under the same submission
K233508 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 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 Bedrock Granite Implant System — Si-Bone Inc.
- iFuse Bedrock 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 6ede0fcb-16a8-4d29-b18b-81bd02bda911 36 fields · synced Jun 8, 2026