DEVICE: AccelFix Spinal Fixation System (08800061315677)
Device Identifier (DI) Information
AccelFix Spinal Fixation System
2300-95120
In Commercial Distribution
2300-95120
L&K BIOMED CO. ,LTD.
2300-95120
In Commercial Distribution
2300-95120
L&K BIOMED CO. ,LTD.
Percutaneous Poly Screw Open Type Ø9.5 , 120mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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46651 | Spinal bone screw, non-bioabsorbable |
A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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KWQ | Appliance, Fixation, Spinal Intervertebral Body |
KWP | Appliance, Fixation, Spinal Interlaminal |
NKB | Thoracolumbosacral Pedicle Screw System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K182544 | 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
d4ddc919-b376-462a-9294-93873abfdb91
June 07, 2024
2
March 16, 2020
June 07, 2024
2
March 16, 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
[?]
No Customer Contact currently defined