DEVICE: Axle Interspinous Fusion System (M697X08033261912STRX1)
Device Identifier (DI) Information
Axle Interspinous Fusion System
X080-332619-12-STRX
In Commercial Distribution
Xtant Medical Holdings, Inc.
X080-332619-12-STRX
In Commercial Distribution
Xtant Medical Holdings, Inc.
IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 12°, 19mm (STERILE), CE MARKED
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? |
---|---|---|---|---|
60847 | Polymeric spinal fusion cage, sterile |
A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OVD | Intervertebral fusion device with integrated fixation, lumbar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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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Width: 33 Millimeter |
Height: 19 Millimeter |
Angle: 12 degree |
Length: 26 Millimeter |
Device Record Status
35909ded-17e6-4ef5-92a1-fe85af4f6f02
June 03, 2021
4
October 30, 2015
June 03, 2021
4
October 30, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(937)847-8400
orders@x-spine.com
orders@x-spine.com