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 8 of 14

Device	Model / Reference	Registries	Class	Status
iFuse Granite Implant System	501402	FDA UDI	Class I	Active
iFuse Granite-Closed Head Implant System	105065CH	FDA UDI	Class II	Active
iFuse Granite Implant System	400302-1100	FDA UDI	Class I	Active
iFuse Bedrock Granite Implant System	095090BG	FDA UDI	Class II	Active
11-Gauge Bone Access Needle	501820	FDA UDI	Class I	Active
iFuse Granite Implant System	400302-0950	FDA UDI	Class I	Active
iFuse Granite Implant System	400309	FDA UDI	Class I	Active
iFuse Granite Implant System	400272-0300	FDA UDI	Class I	Active
iFuse Granite-Closed Head Implant System	115115CH	FDA UDI	Class II	Active
8.7 mm X 155 mm iFuse TORQ TNT Implant	870155	FDA UDI	Class II	Active
iFuse Bedrock Granite Implant System	501858-1050	FDA UDI	Class I	Active
iFuse Implant System	107560-90	FDA UDI	Class II	Active
iFuse TORQ Implant System	11555T	FDA UDI	Class II	Active
iFuse Implant System	107540-90	FDA UDI	Class II	Active
8.7 mm X 165 mm iFuse TORQ TNT Implant	870165	FDA UDI	Class II	Active
iFuse Granite Implant System	125100BG	FDA UDI	Class II	Active
iFuse Implant System	7085M-100	FDA UDI	Class II	Active
iFuse Granite Implant System	501323	FDA UDI	Class I	Active
iFuse TORQ Implant System	13535T	FDA UDI	Class II	Active
iFuse Implant System	7085-90	FDA UDI	Class II	Active
iFuse Granite Implant System	501168	FDA UDI	Class I	Active
iFuse Implant System	7075-90	FDA UDI	Class II	Active
iFuse Granite Implant System	135080BG	FDA UDI	Class II	Active
iFuse Implant System	107580-90	FDA UDI	Class II	Active
iFuse TORQ Implant System	11540LG	FDA UDI	Class II	Active
iFuse Implant System	7040M-90	FDA UDI	Class II	Active
iFuse TORQ Implant System	10075T	FDA UDI	Class II	Active
iFuse Granite Implant System	400278	FDA UDI	Class I	Active
iFuse TORQ Implant System	11530T	FDA UDI	Class II	Active
iFuse Granite-Closed Head Implant System	125060CH	FDA UDI	Class II	Active
iFuse Implant System	7080M-90	FDA UDI	Class II	Active
Mazor Pin, Long Drill Guide 3.0mm	500907	FDA UDI	Class I	Active
iFuse Granite Implant System	105110BG	FDA UDI	Class II	Active
iFuse Granite-Closed Head Implant System	135070CH	FDA UDI	Class II	Active
iFuse TORQ Implant System	10060LG	FDA UDI	Class II	Active
iFuse Granite Implant System	400272-0100	FDA UDI	Class I	Active
iFuse Granite Implant System	400281	FDA UDI	Class I	Active
iFuse TORQ Implant System	13565T	FDA UDI	Class II	Active
iFuse TORQ Implant System	13590T	FDA UDI	Class II	Active
iFuse Granite Implant System	135045BG	FDA UDI	Class II	Active
Guide Pin - 3.2 mm Dia LH Threaded Tip	501385	FDA UDI	Class I	Active
iFuse Granite-Closed Head Implant System	105055CH	FDA UDI	Class II	Active
iFuse Granite Implant System	105120BG	FDA UDI	Class II	Active
8.7 mm X 110 mm iFuse TORQ TNT Implant	870110	FDA UDI	Class II	Active
iFuse Bedrock Granite Implant System	501859-1000	FDA UDI	Class I	Active
iFuse Implant System	7085M-90	FDA UDI	Class II	Active
iFuse Bedrock Granite Implant System	501858-0950	FDA UDI	Class I	Active
iFuse TORQ Implant System	11550T	FDA UDI	Class II	Active
iFuse Granite Implant System	105090BG	FDA UDI	Class II	Active
iFuse Bedrock Granite Implant System	095045BG	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

ICON (LR) Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.