DEVICE: ReBOSSIS (04573190050132)
Device Identifier (DI) Information
ReBOSSIS
0.7g
Not in Commercial Distribution
ORB-0107B
ORTHOREBIRTH CO.,LTD.
0.7g
Not in Commercial Distribution
ORB-0107B
ORTHOREBIRTH CO.,LTD.
ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide). The electrospinning process used in manufacturing ReBOSSIS results in a cotton-like physical form. Due to its physical form, ReBOSSIS is flexible and can easily fill defects in appropriate amounts.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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K142090 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 25 Degrees Celsius |
Special Storage Condition, Specify: Store in a dry place |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 18 Milliliter |
Device Record Status
174714c5-2070-4ff3-9356-4243da250aa1
November 12, 2018
4
September 24, 2015
November 12, 2018
4
September 24, 2015
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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
866-426-2323
dblake@orthorebirthusa.com
dblake@orthorebirthusa.com