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00855369008644

Extractor

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00855369008644
Basic UDI-DI: 081005552ExtractorC8
Reference: 501249
EMDN: L0921
EMDN description: NON-IMPLANTABLE ORTHOPAEDIC DEVICES EXTRACTORS, REUSABLE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00855369008651

Trephine, Large

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00855369008651
Basic UDI-DI: 081005552TrephineBT
Reference: 501250
EMDN: L090902
EMDN description: ORTHOPAEDIC SURGERY TREPHINES, REUSABLE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00855369008422

Reusable drill bit

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00855369008422
Basic UDI-DI: 081005552DrillBitReus2C
Reference: 501154-0700
EMDN: L1104
EMDN description: BITS FOR NEUROSURGERY DRILLS, REUSABLE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007909

Plunger

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007909
Basic UDI-DI: 081005552PlungerGX
Reference: 500861
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007893

Funnel

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007893
Basic UDI-DI: 081005552FunnelSZ
Reference: 500859
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007879

Cap

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007879
Basic UDI-DI: 081005552CapCB
Reference: 500857
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007763

Broach stop

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007763
Basic UDI-DI: 081005552BroachStopYQ
Reference: 500395
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007756

Clamp

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007756
Basic UDI-DI: 081005552ClampBL
Reference: 400106
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007701

Dissector

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007701
Basic UDI-DI: 081005552Dissector3U
Reference: 400064
EMDN: L0926
EMDN description: ORTHOPAEDIC SURGERY DISSECTORS, REUSABLE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007633

Impactor

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007633
Basic UDI-DI: 081005552Impactor3G
Reference: 400194
EMDN: L0903
EMDN description: ORTHOPAEDIC SURGERY HAMMERS, REUSABLE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007305

iFuse 3D Implant

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007305
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7035M-100
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

00851085007206

Guide rod

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007206
Basic UDI-DI: 081005552GuideRodXN
Reference: 500322
EMDN: L0922
EMDN description: ORTHOPAEDIC SURGERY GUIDES, REUSABLE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007145

Guide rod accessory

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007145
Basic UDI-DI: 081005552GuideRodAccessWF
Reference: 500002
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007107

Nav Adaptor- Drill Bit/Tap

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007107
Basic UDI-DI: 081005552Adaptor29
Reference: 500077
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007053

Blade

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007053
Basic UDI-DI: 081005552Blade9Q
Reference: 400096
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007046

Gauge

Class IMDR 2017/745On the marketDirect markingMeasuring functionReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007046
Basic UDI-DI: 081005552GaugeCF
Reference: 500081
EMDN: L0923
EMDN description: ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851085007039

Broach

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007039
Basic UDI-DI: 081005552BroachN4
Reference: 500084
EMDN: L091201
EMDN description: ORTHOPAEDIC SURGERY RASPS, REUSABLE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

00810055524204

iFuse TORQ TNT implant

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055524204
Basic UDI-DI: 081005552tntimplantNE
Reference: 501939-0016
EMDN: P09120603
EMDN description: CANNULATED SCREWS
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

00810055524136

Cleaning Stylet

Class IMDR 2017/745On the marketReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055524136
Basic UDI-DI: 081005552Stylet2M
Reference: 501773
EMDN: V0704
EMDN description: CANNULATED INSTRUMENTS AND DEVICES CLEANING STYLETS
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

00810055524709

Instrument tray

Class IMDR 2017/745On the marketReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055524709
Basic UDI-DI: 081005552SterTrayB5
Reference: 400460
EMDN: S010401
EMDN description: TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details