LnK/OpenLoc-L Spinal Fixation System

GUDID 08800108623277

Crosslink46-54mm

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 08800108623277
• NIH Device Record Key: 0551c425-571d-4196-83b8-74fe5d686acf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK/OpenLoc-L Spinal Fixation System
• Version Model Number: 1043-0054S
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800108623277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200790

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-23
• Device Publish Date: 2020-12-15

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

• 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