DEVICE: Rexious (08800113938755)
Device Identifier (DI) Information
Rexious
A
In Commercial Distribution
BT.MS.100085
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution
BT.MS.100085
DIOMEDICAL CO.,LTD.
Mono-Axial Pedicle E Type (Single & Self Tapping) (L1)103x(L2)85x(A)10x(B)13.5mm-Ø6.0
Device Characteristics
MR Unsafe | |
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? |
---|---|---|---|---|
46653 | Spinal fixation plate, non-bioabsorbable |
A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NKB | Thoracolumbosacral pedicle screw system |
MNH | Orthosis, spondylolisthesis spinal fixation |
MNI | Orthosis, spinal pedicle fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K122229 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d214d714-41fb-4ea6-b191-326579ab961c
September 18, 2023
2
May 21, 2021
September 18, 2023
2
May 21, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+82313699470
112
info@huvexel.com
info@huvexel.com