Is this your brand? Sign in to claim ownership.

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 10 of 14

Device	Model / Reference	Registries	Class	Status
Nav Adaptor- Drill Bit/Tap	500402	EUDAMEDFDA UDI	Class I	Active
Guide	400407	EUDAMEDFDA UDI	Class I	Active
Broach stop	500395	EUDAMEDFDA UDI	Class I	Active
Exchange pin	500091	EUDAMEDFDA UDI	Class IIa	Active
Nav Adaptor- Drill Bit/Tap	400291	EUDAMEDFDA UDI	Class I	Active
Radiolucent Instrument Set (no disposables)	400479	EUDAMED	Class I	Active
Dissector	400064	EUDAMEDFDA UDI	Class I	Active
Guide	400033	EUDAMEDFDA UDI	Class I	Active
Trephine, Large	501250	EUDAMEDFDA UDI	Class I	Active
Tap	501124-1075	EUDAMEDFDA UDI	Class I	Active
Guide rod accessory	500320	EUDAMEDFDA UDI	Class I	Active
XL Instrument Set (no disposables)	400478	EUDAMED	Class I	Active
Sharp pin	500079	EUDAMEDFDA UDI	Class IIa	Active
Guide	501828-0250	EUDAMEDFDA UDI	Class I	Active
Surgical Instrument Sets	400464	EUDAMEDFDA UDI	Class I	Active
Guide	400254	EUDAMEDFDA UDI	Class I	Active
Single-use drill bit	500082	EUDAMEDFDA UDI	Class IIa	Active
Single-use drill bit	500254	EUDAMEDFDA UDI	Class IIa	Active
Nav Adaptor- Drill Bit/Tap	500086	EUDAMEDFDA UDI	Class I	Active
Handle	400011	EUDAMEDFDA UDI	Class I	Active
Gauge	500392	EUDAMEDFDA UDI	Class I	Active
Single-use drill bit	500076	EUDAMEDFDA UDI	Class IIa	Active
Blunt pin	400425-012	EUDAMED	Class IIa	Active
Extractor	501249	EUDAMEDFDA UDI	Class I	Active
Single-use drill bit	501766-0280	EUDAMEDFDA UDI	Class IIa	Active
Dilator	400154	EUDAMEDFDA UDI	Class I	Active
Reusable drill bit	501154-1050	EUDAMEDFDA UDI	Class I	Active
Fixed Tracker Instrument Set	400389	EUDAMEDFDA UDI	Class I	Active
Exchange pin	400425-016	EUDAMED	Class IIa	Active
Single-use drill bit	400426-005	EUDAMED	Class IIa	Active
Guide	400114	EUDAMEDFDA UDI	Class I	Active
Broach	500394	EUDAMEDFDA UDI	Class I	Active
Soft tissue protector	500528	EUDAMEDFDA UDI	Class I	Active
Instrument tray	501970	EUDAMEDFDA UDI	Class I	Active
Guide	400071	EUDAMEDFDA UDI	Class I	Active
Guide	400438	EUDAMEDFDA UDI	Class I	Active
Tap	501126-0925	EUDAMEDFDA UDI	Class I	Active
Sharp pin	500376	EUDAMEDFDA UDI	Class IIa	Active
iFuse Bedrock Granite® Implant System	K222774	FDA 510(k)	Class II	Active
iFuse-TORQ™ Implant System	K203247	FDA 510(k)	Class II	Active
iFuse Implant System- iFuse Navigation	K172268	FDA 510(k)	Class II	Active
iFuse Implant System - iFuse Navigation	K203110	FDA 510(k)	Class II	Active
iFuse Bedrock Granite® Implant System	K233508	FDA 510(k)FDA UDI	Class II	Active
Modification To Si Joint Fusion System	K092375	FDA 510(k)	Class II	Active
iFuse TORQ TNT™ Implant System	K241504	FDA 510(k)	Class II	Active
iFuse Bedrock Granite™ Implant System	K220195	FDA 510(k)	Class II	Active
Navigation Tracking Instruments	K232800	FDA 510(k)	Class II	Active
iFuse INTRA Ti™ Implant System	K253488	FDA 510(k)	Class II	Active
iFuse Implant System® - iFuse-3D implant	K162733	FDA 510(k)	Class II	Active
iFuse-TORQ® Implant System	K213667	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

ICON (LR) Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.