b.Bone

Organization name

GreenBone Ortho Spa

SRN

IT-MF-000033034

Manufacturer status

Active

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

• CW025

  b.Bone implants are of non-metallic inorganic origin. b.Bone implants may be used in combination with metal hardware; refer to the corresponding device’s labeling for additional instructions or information essential to safe use in the MR environment.
• 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

  EUDAMED did not publish a description for this code.
• CW276

  The effect of mixing b.Bone with medicinal products is not known. No negative interactions with bone marrow, autologous blood, and autologous bone graft have been reported based on the history of clinical application of b.Bone material.

Primary placement in Italy; available across 6 countries total.

Trade name

b.Bone

UDI-DI code

08053848341486

Basic UDI-DI

805384834IP01R3D01M01DD

Reference / catalog number

HP201030PS

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

b.Bone, bone substitute, block, 20x10x30 mm, 6.0 cc

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 6 MU12

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• P900401BONE AND TENDON REPLACEMENT DEVICES

Certificate health across this manufacturer's portfolio.