iFuse Bedrock Granite® Implant System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K233508

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 110 mm iFuse Bedrock Granite Closed Head Implant FDA UDI
Model / Reference: 095110CH FDA UDI
Description: 9.5 mm x 110 mm iFuse Bedrock Granite Closed Head Implant FDA UDI

Identifiers

Primary DI / UDI-DI: 00810055524099 FDA UDI
510(k) Number: K233508 FDA 510(k)FDA UDI
FDA Product Code: OUR FDA 510(k)FDA UDI
NKB FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 888.3040 FDA 510(k)
Regulation Number: 888.3040 FDA 510(k)FDA UDI
888.3070 FDA UDI
Advisory Committee: Orthopedic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 9.5 Millimeter FDA UDI
Length — 110 Millimeter FDA UDI

iFuse Bedrock Granite® Implant System by Si-Bone Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K233508	Class II	Active

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Manufacturer

Manufacturer: Si-Bone Inc.
FDA Applicant: SI-BONE, Inc.

Sources (2)

FDA 510(k) K233508 24 fields · synced Jun 19, 2026
FDA UDI ae6d86e3-7bf3-4a68-b3e1-6c9e46dcd1fe 36 fields · synced May 27, 2026