SINTlife Spine

Organization name

Fin-ceramica faenza spa

SRN

IT-MF-000023496

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

5 warnings recorded — scroll inside the panel to see all entries.

• CW010

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

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

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

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

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Primary placement in Italy; available across 6 countries total.

Trade name

SINTlife Spine

UDI-DI code

18054188160727

Basic UDI-DI

B-18054188160727

Reference / catalog number

PFS015057-04-00

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

SINTlife is a range of bone substitutes made of biomimetic hydroxyapatite enriched with magnesium ions in a similar amount as in human bones. SINTlife may 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 combination with osteosynthesis implants and/or prosthesis; • for filling defects due to autologous bone removal or to tumour and cysts removal; • during spinal arthrodesis procedures (interbody fusion and posterolateral fusion), and for spondylolisthesis.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2.5 MU12

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES