PathLoc SI Joint Fusion System PathLoc SI Joint Fusion System BS65-0045S

GUDID 08806344398597

Locking Screw (Cancellous Screw)

L&K BIOMED CO. ,LTD.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 08806344398597
• NIH Device Record Key: 6a4429d8-c2ac-4228-9079-42100a966a5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathLoc SI Joint Fusion System PathLoc SI Joint Fusion System
• Version Model Number: BS65-0045S
• Catalog Number: BS65-0045S
• 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: 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	08806344398597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240201

FDA Product Code

• OUR: Sacroiliac Joint Fixation

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: 2024-04-26
• Device Publish Date: 2024-04-18

On-Brand Devices [PathLoc SI Joint Fusion System PathLoc SI Joint Fusion System]

• 08806344398597: Locking Screw (Cancellous Screw)
• 08806344398498: Locking Screw (Cannulated Screw)