DEVICE: OpenLoc-L Spinal Fixation System (08806344358171)
Device Identifier (DI) Information
OpenLoc-L Spinal Fixation System
1324-85110
In Commercial Distribution
1324-85110
L&K BIOMED CO. ,LTD.
1324-85110
In Commercial Distribution
1324-85110
L&K BIOMED CO. ,LTD.
Poly Axial Screw Ø8.5, 110mm
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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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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FDA Product Code
[?]Product Code | Product Code Name |
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NKB | Thoracolumbosacral Pedicle Screw System |
KWP | Appliance, Fixation, Spinal Interlaminal |
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
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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No Device Sizes |
Device Record Status
3e7bb645-21ff-4cf0-b705-ead1a60ce3e3
May 29, 2024
3
August 28, 2017
May 29, 2024
3
August 28, 2017
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