LnK/PathLoc-L MIS Spinal System

GUDID 08806344394285

MIS Screw, Open Type(Self-tapping), Ø6.5, 45, 97mm

L&K BIOMED CO. ,LTD.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 08806344394285
• NIH Device Record Key: 26497c54-ef24-4a3a-90f8-e9197f5a5196
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK/PathLoc-L MIS Spinal System
• Version Model Number: 2629-6545S
• 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	08806344394285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183117

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-06-14
• Device Publish Date: 2019-01-30

On-Brand Devices [LnK/PathLoc-L MIS Spinal System]

• 08809319759997: MIS Screw, Open Type(Self-tapping), Pi6.5, 45, 67mm
• 08809319759980: MIS Screw, Open Type(Self-tapping), Pi6.5, 40, 67mm
• 08809319758969: MIS Screw, Close Type(Self-tapping), Pi6.5, 55, 107mm
• 08809319758815: MIS Screw, Close Type(Self-tapping), Pi7.5, 50, 97mm
• 08809319756620: MIS Screw, Open Type(Self-tapping, Double Thread), Pi6.5, 40, 87mm
• 08809319756026: MIS Screw, Open Type(Self-tapping, Double Thread), Pi6.5, 55, 57mm
• 08809319752790: MIS Screw, Open Type(Non self-tapping), Pi5.5, 50, 87mm
• 08809319752455: MIS Screw, Open Type(Non self-tapping), Pi6.5, 55, 67mm
• 08809319751915: MIS Screw, Open Type(Non self-tapping), Pi5.5, 30, 47mm
• 08809319750871: MIS Screw, Close Type(Non self-tapping), Pi5.5, 35, 87mm
• 08809319750420: MIS Screw, Close Type(Non self-tapping), Pi7.5, 55, 57mm
• 08809319750383: MIS Screw, Close Type(Non self-tapping), Pi7.5, 35, 57mm
• 08809319759973: MIS Screw, Open Type(Self-tapping), Pi6.5, 35, 67mm
• 08809319759843: MIS Screw, Open Type(Self-tapping), Pi7.5, 40, 57mm
• 08809319759836: MIS Screw, Open Type(Self-tapping), Pi7.5, 35, 57mm
• 08809319759829: MIS Screw, Open Type(Self-tapping), Pi7.5, 30, 57mm
• 08809319759812: MIS Screw, Open Type(Self-tapping), Pi6.5, 60, 57mm
• 08809319759805: MIS Screw, Open Type(Self-tapping), Pi6.5, 55, 57mm
• 08809319759782: MIS Screw, Open Type(Self-tapping), Pi6.5, 45, 57mm
• 08809319759768: MIS Screw, Open Type(Self-tapping), Pi6.5, 35, 57mm
• 08809319759744: MIS Screw, Open Type(Self-tapping), Pi5.5, 60, 57mm
• 08809319759720: MIS Screw, Open Type(Self-tapping), Pi5.5, 50, 57mm
• 08806344395305: MIS Rod, Straight, Pi 5.5, 250mm
• 08806344395282: MIS Rod, Straight, Pi 5.5, 230mm
• 08809319759966: MIS Screw, Open Type(Self-tapping), Pi6.5, 30, 67mm
• 08809319759959: MIS Screw, Open Type(Self-tapping), Pi5.5, 60, 67mm
• 08809319759942: MIS Screw, Open Type(Self-tapping), Pi5.5, 55, 67mm
• 08809319759935: MIS Screw, Open Type(Self-tapping), Pi5.5, 50, 67mm
• 08809319759928: MIS Screw, Open Type(Self-tapping), Pi5.5, 45, 67mm
• 08809319759911: MIS Screw, Open Type(Self-tapping), Pi5.5, 40, 67mm
• 08809319759904: MIS Screw, Open Type(Self-tapping), Pi5.5, 35, 67mm
• 08809319759898: MIS Screw, Open Type(Self-tapping), Pi5.5, 30, 67mm
• 08809319759881: MIS Screw, Open Type(Self-tapping), Pi7.5, 60, 57mm
• 08809319759874: MIS Screw, Open Type(Self-tapping), Pi7.5, 55, 57mm
• 08809319759867: MIS Screw, Open Type(Self-tapping), Pi7.5, 50, 57mm
• 08809319759850: MIS Screw, Open Type(Self-tapping), Pi7.5, 45, 57mm
• 08809319759799: MIS Screw, Open Type(Self-tapping), Pi6.5, 50, 57mm
• 08809319759775: MIS Screw, Open Type(Self-tapping), Pi6.5, 40, 57mm
• 08809319759751: MIS Screw, Open Type(Self-tapping), Pi6.5, 30, 57mm
• 08809319759737: MIS Screw, Open Type(Self-tapping), Pi5.5, 55, 57mm
• 08809319759713: MIS Screw, Open Type(Self-tapping), Pi5.5, 45, 57mm
• 08809319759706: MIS Screw, Open Type(Self-tapping), Pi5.5, 40, 57mm
• 08809319759690: MIS Screw, Open Type(Self-tapping), Pi5.5, 35, 57mm
• 08809319759683: MIS Screw, Open Type(Self-tapping), Pi5.5, 30, 57mm
• 08809319759676: MIS Screw, Open Type(Self-tapping), Pi7.5, 60, 47mm
• 08809319759669: MIS Screw, Open Type(Self-tapping), Pi7.5, 55, 47mm
• 08809319759652: MIS Screw, Open Type(Self-tapping), Pi7.5, 50, 47mm
• 08809319759645: MIS Screw, Open Type(Self-tapping), Pi7.5, 45, 47mm
• 08809319759638: MIS Screw, Open Type(Self-tapping), Pi7.5, 40, 47mm
• 08809319759621: MIS Screw, Open Type(Self-tapping), Pi7.5, 35, 47mm