ENGIpore Ortho

Organization name

Fin-ceramica faenza spa

SRN

IT-MF-000023496

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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• CW010

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 6 countries total.

Trade name

ENGIpore Ortho

UDI-DI code

18054188160215

Basic UDI-DI

B-18054188160215

Reference / catalog number

PFS015005-40-00

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

ENGIpore bone substitutes are made of biomimetic porous hydroxyapatite, which is very similar in its chemical composition and microstructure to the mineral component of vertebrate bones and teeth. ENGIpore bone substitutes can be used to recover bone substance loss, in particular: • in presence of bone defects due to trauma, degenerative diseases of the skeletal system or surgical excisions; • in presence of bone deficiencies following prosthetic implant revisions; • in all pathological conditions in the orthopaedic surgery field that require the generation of new bone tissue.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• dimension — 1–2.5 MU50
• 5 MU12

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES