Organization name

FIXUS BV

SRN

NL-MF-000010820

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  A. Preoperative For safe and effective use of this device, the surgeon must be thoroughly familiar with the system, method of application, instruments, and the recommended surgical technique for this device. This device may only be assembled using components and instruments supplied by Fixus BV. B. Postoperative The external fixator cannot be expected to withstand activity levels in the same way as would a normal human bone. The patient must be cautioned, preferably in writing, about the use, limitations and possible adverse effects of this device including the possibility of the device failing as a result of loose fixation, loosening, stress and excessive activity or weight bearing. The patient must be warned that failure to follow postoperative care instructions can cause the device and/or treatment to fail. Improper alignment can cause a malfuction of the device. Patients should be instructed to report any unusual changes to the operated site to their physician. The patient should be closely monitored if a change at the fracture site has been detected. The surgeon should evaluate the possibility of subsequent clinical failure and discuss with the patient the need for reduced activity in order to aid fracture healing. After a fracture fixation appliance has been removed, the patient should be cautioned to govern their activity levels, as re-fracture can occur. Voids left in the bone after appliance explants, or bone that has not yet fully healed, cannot be expected to withstand stress as would normal healthy bone. Device removal should be followed by adequate postoperative management to avoid re-fracture. All Fixus RECONSTRUCTION fixators and instruments are single use products, products may fail when used more than once. Instruments which have experienced extensive use or excessive force are susceptible to fracture. The device is not tested on MR compatibility.

Primary placement in Netherlands; available across 32 countries total.

Trade name

FIXUS88 Pediatric fixators & parts

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08718104430310

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

871810443RECONF3

Reference / catalog number

n/a, configurable device 5

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

FIXUS88 Pediatric fixators and parts, configurable, black

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P0912040101RADIAL BONE FIXATION SYSTEMS
• P0912040102AXIAL BONE FIXATION SYSTEMS

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.