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Si-Bone Inc.

United States·US-MF-000028624

Last updated September 17, 2026

Information

Country: United States
Address: 471, El Camino Real, Santa Clara, United States
Website: www.si-bone.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1-408-207-0700
PRRC Contact: —
EUDAMED SRN: US-MF-000028624
FDA FEI Number: 3007700286
DUNS Number: 830127168

Catalogue (685)

Page 11 of 14

Device	Model / Reference	Registries	Class	Status
Si Joint Fusion System	K080398	FDA 510(k)	Class II	Active
Neuromonitoring Kit	K161893	FDA 510(k)	Class II	Active
iFuse Implant System(R)	K152681	FDA 510(k)	Class II	Active
iGPS Navigation Instruments	K251780	FDA 510(k)	Class II	Active
iFuse TORQ® Implant System	K231689	FDA 510(k)	Class II	Active
iFuse TORQ® Implant System	K222605	FDA 510(k)	Class II	Active
iFuse TORQ® Implant System	K241574	FDA 510(k)	Class II	Active
iFuse Bedrock Granite Implant System	K253094	FDA 510(k)	Class II	Active
Soft tissue protector	400408	EUDAMEDFDA UDI	Class I	Active
Single-use drill bit	400146	EUDAMEDFDA UDI	Class IIa	Active
Navigated drill bit	501122-1050	EUDAMEDFDA UDI	Class I	Active
Nav Adaptor- Drill Bit/Tap	400290	EUDAMEDFDA UDI	Class I	Active
Sleeve	400034	EUDAMEDFDA UDI	Class I	Active
Impactor	500244	EUDAMEDFDA UDI	Class I	Active
Navigation Instrument Set	400200	EUDAMEDFDA UDI	Class I	Active
Sharp pin	400425-014	EUDAMED	Class IIa	Active
Guide	500858	EUDAMEDFDA UDI	Class I	Active
Nav Adaptor- Drill Bit/Tap	500077	EUDAMEDFDA UDI	Class I	Active
Blunt pin	400425-002	EUDAMED	Class IIa	Active
Soft tissue protector	500623	EUDAMEDFDA UDI	Class I	Active
Guide	400113	EUDAMEDFDA UDI	Class I	Active
Sleeve	500072	EUDAMEDFDA UDI	Class I	Active
Gauge	400164	EUDAMEDFDA UDI	Class I	Active
Tap	501126-0925	EUDAMEDFDA UDI	Class I	Active
Cleaning Stylet	501773	EUDAMEDFDA UDI	Class I	Active
Soft tissue protector	400158	EUDAMEDFDA UDI	Class I	Active
Guide	501829-0200	EUDAMEDFDA UDI	Class I	Active
Guide rod	400196	EUDAMEDFDA UDI	Class I	Active
iFuse TORQ Instrument Set	400287	EUDAMEDFDA UDI	Class I	Active
Dilator	501161	EUDAMEDFDA UDI	Class I	Active
Sharp threaded pin	500842	EUDAMEDFDA UDI	Class IIa	Active
XL Instrument Set	400062	EUDAMEDFDA UDI	Class I	Active
Clamp	400106	EUDAMEDFDA UDI	Class I	Active
Exchange pin	500375	EUDAMEDFDA UDI	Class IIa	Active
Broach	500248	EUDAMEDFDA UDI	Class I	Active
Impactor	500243	EUDAMEDFDA UDI	Class I	Active
Single-use drill bit	400426-004	EUDAMED	Class IIa	Active
Guide rod	400195	EUDAMEDFDA UDI	Class I	Active
Handle	400283	EUDAMEDFDA UDI	Class I	Active
Impactor	400070	EUDAMEDFDA UDI	Class I	Active
Guide rod	500322	EUDAMEDFDA UDI	Class I	Active
Sleeve	500241	EUDAMEDFDA UDI	Class I	Active
Gauge	500081	EUDAMEDFDA UDI	Class I	Active
Blunt pin	500251	EUDAMEDFDA UDI	Class IIa	Active
Impactor	400194	EUDAMEDFDA UDI	Class I	Active
Guide rod accessory	500258	EUDAMEDFDA UDI	Class I	Active
Impactor	500628	EUDAMEDFDA UDI	Class I	Active
Exchange pin	500378	EUDAMEDFDA UDI	Class IIa	Active
Soft tissue protector	400066	EUDAMEDFDA UDI	Class I	Active
Sleeve	500242	EUDAMEDFDA UDI	Class I	Active

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