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Trephine, Large

by SI-BONE, Inc. 2 variants

Ref 501252

Trephine, Large (501252) is a Class I device made by Si-Bone Inc., registered in EUDAMED on 7 Jan 2025 (Basic UDI-DI 081005552TrephineBT) and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 00855369008668), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081005552TrephineBT Basic UDI-DI 00855369008668UDI-DIDate7 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00855369008668 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081005552TrephineBT registered 7 Jan 2025 Active
  • FDA GUDID UDI-DI 00855369008668 listed 8 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00855369008668
  2. Registered EUDAMED 081005552TrephineBT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Model / reference
501252
Primary DI / UDI-DI
00855369008668
Basic UDI-DI
081005552TrephineBT
Direct marketing DI
00855369008668
FDA product code
LXH
EMDN code
L090902 Orthopaedic surgery trephines, reusable
GMDN term
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000028624
Authorised representative
ICON (LR) Limited IE-AR-000006507

Related devices

Category: Bone trephine, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE.

Other devices from Si-Bone Inc.

See all devices from Si-Bone Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)