RegenOss Spine

Organization name

Fin-ceramica faenza spa

SRN

IT-MF-000023496

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW010

  EUDAMED did not publish a description for this code.
• CW267

  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

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 6 countries total.

Trade name

RegenOss Spine

UDI-DI code

18054188160758

Basic UDI-DI

B-18054188160758

Reference / catalog number

01600821

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

RegenOss is a medical device for bone defect reconstruction. RegenOss is an implantable, reabsorbable, non-active medical device, acting as bone substitute. RegenOss is indicated for recovering 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; • 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

• dimension 1 — 2.5 MU10
• dimension 2 — 7.5 MU10
• dimension 3 — 0.5 MU10

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES