PathLoc-TA Expandable Lumbar Cage System 2938-1506S

GUDID 08800108699173

PathLoc-TA D29XW38, H6~10, A15

L&K BIOMED CO. ,LTD.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 08800108699173
• NIH Device Record Key: bf5b8550-cf12-485c-a519-6b4342fa5854
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathLoc-TA Expandable Lumbar Cage System
• Version Model Number: 2938-1506S
• Catalog Number: 2938-1506S
• 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	08800108699173 [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: 2023-02-09
• Device Publish Date: 2023-02-01

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