Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Si-Bone Inc.

Address:

471 El Camino Real Suite 101

Santa Clara

California 95050

United States

Authorised Representative/ UK Responsible Person
Name: ICON (LR) Limited
Address:

Concept House 6 Stoneycroft Rise

Chandlers Ford Eastleigh

Hampshire

SO53 3LD

England United Kingdom

Code/Term Type

Sacroiliac joint transarticular fixation/arthrodesis implant coated Sacroiliac joint transarticular fixation/arthrodesis implant coated Class IIb

Fluted surgical drill bit reusable Fluted surgical drill bit reusable Class IIa

Orthopaedic bone pin non-bioabsorbable Orthopaedic bone pin non-bioabsorbable Class IIa

Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Class I

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Sacroiliac joint transarticular fixation/arthrodesis implant coated	Sacroiliac joint transarticular fixation/arthrodesis implant coated	Class IIb
Fluted surgical drill bit reusable	Fluted surgical drill bit reusable	Class IIa
Orthopaedic bone pin non-bioabsorbable	Orthopaedic bone pin non-bioabsorbable	Class IIa
Sacroiliac joint transarticular fixation/arthrodesis implantation kit	Sacroiliac joint transarticular fixation/arthrodesis implantation kit	Class I