DEVICE: Vertefix (06009696221441)
Device Identifier (DI) Information
Vertefix
MAE6545T
In Commercial Distribution
MAE6545T
ELITE SURGICAL SUPPLIES (PTY) LTD
MAE6545T
In Commercial Distribution
MAE6545T
ELITE SURGICAL SUPPLIES (PTY) LTD
Multi Axial Extension Pedicle Screw 6.5x45mm
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
37272 | Trans-facet-screw internal spinal fixation system, sterile |
A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
MNI | Orthosis, Spinal Pedicle Fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
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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No Device Sizes |
Device Record Status
45c29bd2-2b98-4b24-b049-10342924289d
January 17, 2019
4
September 23, 2016
January 17, 2019
4
September 23, 2016
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
[?]
No Customer Contact currently defined