DEVICE: TirboLOX-C Cervical IBFD (M7391815710140)
Device Identifier (DI) Information
TirboLOX-C Cervical IBFD
18157-1014
In Commercial Distribution
CAPTIVA SPINE, INC.
18157-1014
In Commercial Distribution
CAPTIVA SPINE, INC.
Lordotic 7° Cage 14.5mm x 12mm x 10mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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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? |
---|---|---|---|---|
47139 | Spinal fusion sphere |
A sterile implantable metal sphere used to stabilize interspinous processes from L3 to S1 to promote intervertebral body fusion. It is inserted into the disc space between two vertebral bodies, and is specifically designed to be used with a bone graft to hold the bones in alignment while they heal and fuse. The device is typically made of a high-grade medical cobalt-chrome (Co-Cr) or Cobalt-Chrome-Molybdenum (Co-Cr-Mo).
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K181229 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
aa1510f3-905f-4c0e-9921-9c347ad0e11d
November 30, 2020
1
November 22, 2020
November 30, 2020
1
November 22, 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
[?]
561-277-9480
info@captivaspine.com
info@captivaspine.com