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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 12 of 14

Device	Model / Reference	Registries	Class	Status
Standard Instrument Set	400099	EUDAMEDFDA UDI	Class I	Active
Guide rod	500511	EUDAMEDFDA UDI	Class I	Active
Nav Adaptor- Drill Bit/Tap	500245	EUDAMEDFDA UDI	Class I	Active
Sleeve	400065	EUDAMEDFDA UDI	Class I	Active
Single-use drill bit	400426-001	EUDAMED	Class IIa	Active
Sharp threaded pin	501917	EUDAMEDFDA UDI	Class IIa	Active
Clamp	400072	EUDAMEDFDA UDI	Class I	Active
Instrument tray	400460	EUDAMEDFDA UDI	Class I	Active
Power adaptor	501417	EUDAMEDFDA UDI	Class IIa	Active
Tracker	400372-0002	EUDAMEDFDA UDI	Class I	Active
Cap	500857	EUDAMEDFDA UDI	Class I	Active
Guide	400402	EUDAMEDFDA UDI	Class I	Active
Tap	501126-1275	EUDAMEDFDA UDI	Class I	Active
Navigated drill bit	501122-0850	EUDAMEDFDA UDI	Class I	Active
Chisel	500532	EUDAMEDFDA UDI	Class I	Active
Impactor	500627	EUDAMEDFDA UDI	Class I	Active
Soft tissue protector	500070	EUDAMEDFDA UDI	Class I	Active
Handle	501514	EUDAMEDFDA UDI	Class I	Active
Nav Adaptor- Drill Bit/Tap	500246	EUDAMEDFDA UDI	Class I	Active
Impactor	400030	EUDAMEDFDA UDI	Class I	Active
Guide	400253	EUDAMEDFDA UDI	Class I	Active
Driver	501872	EUDAMEDFDA UDI	Class I	Active
7.5mm/10.75mm iFuse Implant System Instrument Set (no disposables)	400480	EUDAMED	Class I	Active
Nav Adaptor- Drill Bit/Tap	500403	EUDAMEDFDA UDI	Class I	Active
Broach	400256	EUDAMEDFDA UDI	Class I	Active
Sharp pin	500373	EUDAMEDFDA UDI	Class IIa	Active
Tap	501157-1275	EUDAMEDFDA UDI	Class I	Active
Blunt pin	501918-0450	EUDAMEDFDA UDI	Class IIa	Active
Sleeve	400035	EUDAMEDFDA UDI	Class I	Active
Driver	501129	EUDAMEDFDA UDI	Class I	Active
Broach	500084	EUDAMEDFDA UDI	Class I	Active
Driver	400424	EUDAMEDFDA UDI	Class I	Active
Sharp pin	500252	EUDAMEDFDA UDI	Class IIa	Active
iFuse TORQ Instrument Set, FT	400468	EUDAMED	Class I	Active
Dissector	400224	EUDAMEDFDA UDI	Class I	Active
Chisel	500262	EUDAMEDFDA UDI	Class I	Active
Sharp pin	501770-0330	EUDAMEDFDA UDI	Class IIa	Active
Blunt pin	500249	EUDAMEDFDA UDI	Class IIa	Active
Soft tissue protector	500622	EUDAMEDFDA UDI	Class I	Active
Blunt pin	400425-005	EUDAMED	Class IIa	Active
Sharp pin	501769-0330	EUDAMEDFDA UDI	Class IIa	Active
Tap	501124-0925	EUDAMEDFDA UDI	Class I	Active
Tracker	400372-0001	EUDAMEDFDA UDI	Class I	Active
Sleeve	400262	EUDAMEDFDA UDI	Class I	Active
Sleeve	400023	EUDAMEDFDA UDI	Class I	Active
Dilator	501130	EUDAMEDFDA UDI	Class I	Active
Soft tissue protector	501775	EUDAMEDFDA UDI	Class I	Active
Tap	400418	EUDAMEDFDA UDI	Class I	Active
Guide	500259	EUDAMEDFDA UDI	Class I	Active
Trephine, Large	501252	EUDAMEDFDA UDI	Class I	Active

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