LnK/OpenLoc-L Spinal Fixation System

GUDID 08806344396869

SAI Screw (Full Thread), Cannulated, Pi9.0, 110mm

L&K BIOMED CO. ,LTD.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable

• Primary Device ID: 08806344396869
• NIH Device Record Key: 57b79afe-d99a-447b-83f1-cb4cea0078d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK/OpenLoc-L Spinal Fixation System
• Version Model Number: 1375-90110
• 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	08806344396869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183168

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

[08806344396869]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-05-28
• Device Publish Date: 2019-02-10

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

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• 08806344397132: Crosslink 40-53mm
• 08806344397125: Crosslink 34-42mm
• 08806344397118: Crosslink 30-34mm
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• 08800108623253: Crosslink34-42mm
• 08800108623246: Crosslink30-34mm
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• 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
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• 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