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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

K-wire fixation device — Class I MDR by ProSpon, spol. s r.o.

MD Atlas
ProSpon, spol. s r.o.

EUDAMED last updated this device on May 27, 2026

K-wire fixation device

8592395HYBRIDBB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ProSpon, spol. s r.o.
UDI-DI code: 08595565101405
Reference / catalog number: F0060105

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View device family (Basic UDI)

Manufacturer information

Organization name: ProSpon, spol. s r.o.
SRN: CZ-MF-000019992
Manufacturer status: Active

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: K-wire fixation device
UDI-DI code: 08595565101405
Basic UDI-DI: 8592395HYBRIDBB
Reference / catalog number: F0060105
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: External fixator for the intended purpose of reposition, fixation and prolongation.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

P0912040101RADIAL BONE FIXATION SYSTEMS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Certificates

Certificate health across this manufacturer's portfolio.

2026-MDR/TD-003Issued
Technical documentationNotified body: 2265Expiry: Apr 26, 2029
2026-MDR/QS-003Issued
Quality management systemNotified body: 2265Expiry: Apr 26, 2029