LnK/OpenLoc-L Spinal Fixation System

GUDID 08800108623277

Crosslink46-54mm

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector
Primary Device ID08800108623277
NIH Device Record Key0551c425-571d-4196-83b8-74fe5d686acf
Commercial Distribution StatusIn Commercial Distribution
Brand NameLnK/OpenLoc-L Spinal Fixation System
Version Model Number1043-0054S
Company DUNS631159324
Company NameL&K BIOMED CO. ,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800108623277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-23
Device Publish Date2020-12-15

On-Brand Devices [LnK/OpenLoc-L Spinal Fixation System]

08806344397149Crosslink 50-70mm
08806344397132Crosslink 40-53mm
08806344397125Crosslink 34-42mm
08806344397118Crosslink 30-34mm
08806344348288Mono Axial Screw Ø7.0, 70mm
08806344348295Mono Axial Screw Ø7.0, 75mm
08800108623277Crosslink46-54mm
08800108623260Crosslink40-48mm
08800108623253Crosslink34-42mm
08800108623246Crosslink30-34mm
08806344396654SAI Screw (Smooth Shank), Non-Cannulated, Pi9.0, 80mm
08806344396418SAI Screw (Smooth Shank), Cannulated, Pi8.0, 80mm
08806344396401SAI Screw (Smooth Shank), Cannulated, Pi8.0, 70mm
08806344396388Crosslink 50-70mm
08806344396371Crosslink 40-53mm
08806344396357Crosslink 30-34mm
08806344396340Reduction Mono Screw, Pi6.5, 150mm
08806344396333Reduction Mono Screw, Pi6.5, 145mm
08806344396326Reduction Mono Screw, Pi6.5, 140mm
08806344396319Reduction Mono Screw, Pi6.5, 135mm
08806344396302Reduction Mono Screw, Pi6.5, 130mm
08806344396296Reduction Mono Screw, Pi6.5, 125mm
08806344396289Reduction Mono Screw, Pi6.5, 120mm
08806344396272Reduction Mono Screw, Pi6.5, 115mm
08806344396265Reduction Mono Screw, Pi6.5, 100mm
08806344397101SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 110mm
08806344397095SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 100mm
08806344397088SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 90mm
08806344397071SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 80mm
08806344397064SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 70mm
08806344397057SAI Screw (Full Thread), Non-Cannulated, Pi10.0, 60mm
08806344397040SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 110mm
08806344397033SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 100mm
08806344397026SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 90mm
08806344397019SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 80mm
08806344397002SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 70mm
08806344396999SAI Screw (Full Thread), Non-Cannulated, Pi9.0, 60mm
08806344396982SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 110mm
08806344396975SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 100mm
08806344396968SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 90mm
08806344396951SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 80mm
08806344396944SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 70mm
08806344396937SAI Screw (Full Thread), Non-Cannulated, Pi8.0, 60mm
08806344396920SAI Screw (Full Thread), Cannulated, Pi10.0, 110mm
08806344396913SAI Screw (Full Thread), Cannulated, Pi10.0, 100mm
08806344396906SAI Screw (Full Thread), Cannulated, Pi10.0, 90mm
08806344396890SAI Screw (Full Thread), Cannulated, Pi10.0, 80mm
08806344396883SAI Screw (Full Thread), Cannulated, Pi10.0, 70mm
08806344396876SAI Screw (Full Thread), Cannulated, Pi10.0, 60mm
08806344396869SAI Screw (Full Thread), Cannulated, Pi9.0, 110mm
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