LnK Anterior Cervical Plate System

GUDID 08809986479471

Cervical Plate(4 Level 97mm)

L&K BIOMED CO. ,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08809986479471
• NIH Device Record Key: f5db850b-e33b-4872-9582-b045bc853c0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK Anterior Cervical Plate System
• Version Model Number: 6514-1797
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08809986479471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143279

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

[08809986479471]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-18
• Device Publish Date: 2025-04-10

On-Brand Devices [LnK Anterior Cervical Plate System]

• 08809986479471: Cervical Plate(4 Level 97mm)
• 08809986479464: Cervical Plate(4 Level 65mm)
• 08809986479457: Cervical Plate(3 Level 48mm)
• 08809986479440: Cervical Plate(2 Level 35mm)