DEVICE: BonOs Inject (04260056883231)

Device Identifier (DI) Information

BonOs Inject
01-0309
In Commercial Distribution

OSARTIS GmbH
04260056883231
GS1

1
344261631 *Terms of Use
BonOs® Inject is a radiopaque, injectable bone cement for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure. When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. Mixing the two separate sterile components initially produces a ductile, injectable bone cement which, after hardening in situ, is able to stabilize neoplastic vertebral lesions and vertebral compression fractures. BonOs® Inject cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60505 Vertebral bone filler, non-bioabsorbable
A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NDN Cement, Bone, Vertebroplasty
LOD Bone Cement
NKD Stimulator, Spinal Cord, Implanted For Female Sexual Dysfunction
PML Bone Cement, Posterior Screw Augmentation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store between 0°C (32°F) and 25°C (77°F)
Handling Environment Temperature: between 18 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 24 Gram
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Device Record Status

99513783-9a2c-4618-8ccd-728c4c70927d
June 12, 2023
5
October 02, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14260056883238 20 04260056883231 In Commercial Distribution Shipping unit
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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