PathLoc-TA Expandable Lumbar Cage System 2432-3015S

GUDID 08800108699104

PathLoc-TA D24XW32, H15~19, A30

L&K BIOMED CO. ,LTD.

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• Primary Device ID: 08800108699104
• NIH Device Record Key: 823cb532-751b-4669-ac00-9f42edd34ad7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathLoc-TA Expandable Lumbar Cage System
• Version Model Number: 2432-3015S
• Catalog Number: 2432-3015S
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	08800108699104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223474

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

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: 2023-10-27
• Device Publish Date: 2023-10-19

On-Brand Devices [PathLoc-TA Expandable Lumbar Cage System]

• 08800108699173: PathLoc-TA D29XW38, H6~10, A15
• 08800108699111: PathLoc-TA D29XW38, H9~13, A8
• 08800108698954: PathLoc-TA D24XW32, H6~10, A15
• 08800108698893: PathLoc-TA D24XW32, H9~13, A8
• 08800108699104: PathLoc-TA D24XW32, H15~19, A30