DEVICE: SIGNAFUSE Bioactive Bone Graft (00816986020495)
Device Identifier (DI) Information
SIGNAFUSE Bioactive Bone Graft
50X25X8 MM, 10 CC
In Commercial Distribution
SGFS-010
BIOVENTUS LLC
50X25X8 MM, 10 CC
In Commercial Distribution
SGFS-010
BIOVENTUS LLC
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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16966 | Synthetic bone graft |
An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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MQV | Filler, Bone Void, Calcium Compound |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K193513 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
afa7e5a3-f627-4a21-9f3e-fa3bedac3495
August 07, 2020
1
July 30, 2020
August 07, 2020
1
July 30, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-637-4391
CSSurgical@bioventusglobal.com
CSSurgical@bioventusglobal.com