Primary Device ID | 08806344396333 |
NIH Device Record Key | 843f58b3-ccb6-4d43-9350-1ac3a79ac1ab |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LnK/OpenLoc-L Spinal Fixation System |
Version Model Number | 1331-65145 |
Company DUNS | 631159324 |
Company Name | L&K BIOMED CO. ,LTD. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08806344396333 [Primary] |
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
[08806344396333]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-05-27 |
Device Publish Date | 2019-02-10 |
08806344397149 | Crosslink 50-70mm |
08806344397132 | Crosslink 40-53mm |
08806344397125 | Crosslink 34-42mm |
08806344397118 | Crosslink 30-34mm |
08806344348288 | Mono Axial Screw Ø7.0, 70mm |
08806344348295 | Mono Axial Screw Ø7.0, 75mm |
08800108623277 | Crosslink46-54mm |
08800108623260 | Crosslink40-48mm |
08800108623253 | Crosslink34-42mm |
08800108623246 | Crosslink30-34mm |
08806344396654 | SAI Screw (Smooth Shank), Non-Cannulated, Pi9.0, 80mm |
08806344396418 | SAI Screw (Smooth Shank), Cannulated, Pi8.0, 80mm |
08806344396401 | SAI Screw (Smooth Shank), Cannulated, Pi8.0, 70mm |
08806344396388 | Crosslink 50-70mm |
08806344396371 | Crosslink 40-53mm |
08806344396357 | Crosslink 30-34mm |
08806344396340 | Reduction Mono Screw, Pi6.5, 150mm |
08806344396333 | Reduction Mono Screw, Pi6.5, 145mm |
08806344396326 | Reduction Mono Screw, Pi6.5, 140mm |
08806344396319 | Reduction Mono Screw, Pi6.5, 135mm |
08806344396302 | Reduction Mono Screw, Pi6.5, 130mm |
08806344396296 | Reduction Mono Screw, Pi6.5, 125mm |
08806344396289 | Reduction Mono Screw, Pi6.5, 120mm |
08806344396272 | Reduction Mono Screw, Pi6.5, 115mm |
08806344396265 | Reduction Mono Screw, Pi6.5, 100mm |
08806344397101 | SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 110mm |
08806344397095 | SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 100mm |
08806344397088 | SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 90mm |
08806344397071 | SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 80mm |
08806344397064 | SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 70mm |
08806344397057 | SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 60mm |
08806344397040 | SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 110mm |
08806344397033 | SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 100mm |
08806344397026 | SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 90mm |
08806344397019 | SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 80mm |
08806344397002 | SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 70mm |
08806344396999 | SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 60mm |
08806344396982 | SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 110mm |
08806344396975 | SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 100mm |
08806344396968 | SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 90mm |
08806344396951 | SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 80mm |
08806344396944 | SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 70mm |
08806344396937 | SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 60mm |
08806344396920 | SAI Screw (Full Thread), Cannulated, Pi10.0, 110mm |
08806344396913 | SAI Screw (Full Thread), Cannulated, Pi10.0, 100mm |
08806344396906 | SAI Screw (Full Thread), Cannulated, Pi10.0, 90mm |
08806344396890 | SAI Screw (Full Thread), Cannulated, Pi10.0, 80mm |
08806344396883 | SAI Screw (Full Thread), Cannulated, Pi10.0, 70mm |
08806344396876 | SAI Screw (Full Thread), Cannulated, Pi10.0, 60mm |
08806344396869 | SAI Screw (Full Thread), Cannulated, Pi9.0, 110mm |