DEVICE: Addivation Medical Cervical Interbody Device (B804AOCS61291)
Device Identifier (DI) Information
Addivation Medical Cervical Interbody Device
AOCS6129
In Commercial Distribution
ADDIVATION MEDICAL, LLC
AOCS6129
In Commercial Distribution
ADDIVATION MEDICAL, LLC
Cervical Spine Interbody Device. 12 x 14mm footprint, 9mm height, 6 degrees lordosis.
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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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 |
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ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K190291 | 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
e4e21c0c-cb7b-46bf-9e39-245a1e87bcd4
June 11, 2020
1
June 03, 2020
June 11, 2020
1
June 03, 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
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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
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No Customer Contact currently defined