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Organization name
UDI-DI code
Reference / catalog number

FIXION PENTA interference screw — Class III MDR by EVOLUTIS

MD Atlas
EVOLUTIS

EUDAMED last updated this device on Jan 10, 2025

FIXION PENTA interference screw

376025538P091203KVS

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EVOLUTIS
UDI-DI code: 03760255383385
Reference / catalog number: G25 K08020

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Manufacturer information

Organization name: EVOLUTIS
SRN: FR-MF-000000492
Manufacturer status: Active

Related devices

FIXIO PENTA interference screw376025538P091203KVSOn the market FIXION PENTA interference screw376025538P091203KVSOn the market FIXION PENTA interference screw376025538P091203KVSOn the market FIXION PENTA interference screw376025538P091203KVSOn the market FIXION PENTA interference screw376025538P091203KVSOn the market

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Germany		Still on market
Italy		Still on market

Device identification

Trade name: FIXION PENTA interference screw
UDI-DI code: 03760255383385
Basic UDI-DI: 376025538P091203KVS
Reference / catalog number: G25 K08020
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: FIXION PENTA interfer. screw Ø8 Lg. 20mm PLDLLA
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P09120606OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

016-00-04-MDRSupplemented
Quality management systemNotified body: 0426Expiry: Apr 5, 2028
074-00-00-MDRWithdrawn
Quality management systemNotified body: 0426Expiry: Apr 21, 2030
055-00-00-MDRIssued
Technical documentationNotified body: 0426Expiry: Sep 11, 2029
017-00-00-MDRIssued
Technical documentationNotified body: 0426Expiry: Apr 5, 2028