LnK/OpenLoc-L Spinal Fixation System

GUDID 08800108623253

Crosslink34-42mm

L&K BIOMED CO. ,LTD.

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• Primary Device ID: 08800108623253
• NIH Device Record Key: 3342678f-2dff-4d47-842c-c9cd00d4993b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK/OpenLoc-L Spinal Fixation System
• Version Model Number: 1043-0042S
• 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	08800108623253 [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