"LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System"

GUDID 08809986467638

SAI Screw Smooth Shank D8.5 X 90mm

L&K BIOMED CO. ,LTD.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 08809986467638
• NIH Device Record Key: b1397fa4-081b-4998-8f6b-3fd32c9cc3e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System"
• Version Model Number: 1374-8590
• 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	08809986467638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200790

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

Moist Heat or Steam Sterilization

[08809986467638]

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 Spinal Fixation System/ OpenLoc-L Spinal Fixation System"]

• 08809986467799: SAI Screw Full Thread D8.5 X 70mm
• 08809986467782: SAI Screw Full Thread D8.5 X 60mm
• 08809986467775: SAI Screw Smooth Shank D10.5 X 110mm
• 08809986467768: SAI Screw Smooth Shank D10.5 X 100mm
• 08809986467751: SAI Screw Smooth Shank D10.5 X 90mm
• 08809986467744: SAI Screw Smooth Shank D10.5 X 80mm
• 08809986467737: SAI Screw Smooth Shank D10.5 X 70mm
• 08809986467720: SAI Screw Smooth Shank D10.5 X 60mm
• 08809986467713: SAI Screw Smooth Shank D9.5 X 110mm
• 08809986467706: SAI Screw Smooth Shank D9.5 X 100mm
• 08809986467690: SAI Screw Smooth Shank D9.5 X 90mm
• 08809986467683: SAI Screw Smooth Shank D9.5 X 80mm
• 08809986467676: SAI Screw Smooth Shank D9.5 X 70mm
• 08809986467669: SAI Screw Smooth Shank D9.5 X 60mm
• 08809986467652: SAI Screw Smooth Shank D8.5 X 110mm
• 08809986467645: SAI Screw Smooth Shank D8.5 X 100mm
• 08809986467638: SAI Screw Smooth Shank D8.5 X 90mm
• 08809986467621: SAI Screw Smooth Shank D8.5 X 80mm
• 08809986467614: SAI Screw Smooth Shank D8.5 X 70mm
• 08809986467607: SAI Screw Smooth Shank D8.5 X 60mm
• 08809986467591: SAI Screw Smooth Shank D10.5 X 110mm
• 08809986467584: SAI Screw Smooth Shank D10.5 X 100mm
• 08809986467577: SAI Screw Smooth Shank D10.5 X 90mm
• 08809986467560: SAI Screw Smooth Shank D10.5 X 80mm
• 08809986467553: SAI Screw Smooth Shank D10.5 X 70mm
• 08809986467546: SAI Screw Smooth Shank D10.5 X 60mm
• 08809986467539: SAI Screw Smooth Shank D9.5 X 110mm
• 08809986467522: SAI Screw Smooth Shank D9.5 X 100mm
• 08809986467515: SAI Screw Smooth Shank D9.5 X 90mm
• 08809986467508: SAI Screw Smooth Shank D9.5 X 80mm
• 08809986467492: SAI Screw Smooth Shank D9.5 X 70mm
• 08809986467485: SAI Screw Smooth Shank D9.5 X 60mm
• 08809986467478: SAI Screw Smooth Shank D8.5 X 110mm
• 08809986467461: SAI Screw Smooth Shank D8.5 X 100mm
• 08809986467454: SAI Screw Smooth Shank D8.5 X 90mm
• 08809986467447: SAI Screw Smooth Shank D8.5 X 80mm
• 08809986467430: SAI Screw Smooth Shank D8.5 X 70mm
• 08809986467423: SAI Screw Smooth Shank D8.5 X 60mm