PathLoc Lumbar Interbody Fusion System PT2511-1020

GUDID 08800108663327

PathLoc - TM L25XW11, H10~14, A20

L&K BIOMED CO. ,LTD.

Metallic spinal interbody fusion cage

• Primary Device ID: 08800108663327
• NIH Device Record Key: 3225491d-b8a5-46a1-a5a9-6393af2a6f62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathLoc Lumbar Interbody Fusion System
• Version Model Number: PT2511-1020
• Catalog Number: PT2511-1020
• 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	08800108663327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213441

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[08800108663327]

Moist Heat or Steam Sterilization

[08800108663327]

Moist Heat or Steam Sterilization

[08800108663327]

Moist Heat or Steam Sterilization

[08800108663327]

Moist Heat or Steam Sterilization

[08800108663327]

Moist Heat or Steam Sterilization

[08800108663327]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-20
• Device Publish Date: 2022-05-12

On-Brand Devices [PathLoc Lumbar Interbody Fusion System]

• 08800108663563: PathLoc - TM L22XW11, H12~16, A20
• 08800108663556: PathLoc - TM L22XW11, H12~16, A15
• 08800108663532: PathLoc - TM L22XW11, H12~16, A08
• 08800108663518: PathLoc - TM L22XW11, H12~16, A00
• 08800108663501: PathLoc - TM L22XW11, H10~14, A20
• 08800108663495: PathLoc - TM L22XW11, H10~14, A15
• 08800108663471: PathLoc - TM L22XW11, H10~14, A08
• 08800108663457: PathLoc - TM L22XW11, H10~14, A00
• 08800108663440: PathLoc - TM L22XW11, H08~12, A20
• 08800108663433: PathLoc - TM L22XW11, H08~12, A15
• 08800108663419: PathLoc - TM L22XW11, H08~12, A08
• 08800108663396: PathLoc - TM L22XW11, H08~12, A00
• 08800108663037: PathLoc - TM L22XW11, H08~12, A00
• 08800108663679: PathLoc - TM L25XW11, H10~14, A15
• 08800108663662: PathLoc - TM L25XW11, H10~14, A12
• 08800108663655: PathLoc - TM L25XW11, H10~14, A08
• 08800108663648: PathLoc - TM L25XW11, H10~14, A04
• 08800108663631: PathLoc - TM L25XW11, H10~14, A00
• 08800108663617: PathLoc - TM L25XW11, H08~12, A15
• 08800108663600: PathLoc - TM L25XW11, H08~12, A12
• 08800108663594: PathLoc - TM L25XW11, H08~12, A08
• 08800108663488: PathLoc - TM L22XW11, H10~14, A12
• 08800108663464: PathLoc - TM L22XW11, H10~14, A04
• 08800108663426: PathLoc - TM L22XW11, H08~12, A12
• 08800108663402: PathLoc - TM L22XW11, H08~12, A04
• 08800108663389: PathLoc - TM L25XW11, H12~16, A20
• 08800108663372: PathLoc - TM L25XW11, H12~16, A15
• 08800108663365: PathLoc - TM L25XW11, H12~16, A12
• 08800108663358: PathLoc - TM L25XW11, H12~16, A08
• 08800108663341: PathLoc - TM L25XW11, H12~16, A04
• 08800108663334: PathLoc - TM L25XW11, H12~16, A00
• 08800108663327: PathLoc - TM L25XW11, H10~14, A20
• 08800108663310: PathLoc - TM L25XW11, H10~14, A15
• 08800108663303: PathLoc - TM L25XW11, H10~14, A12
• 08800108663297: PathLoc - TM L25XW11, H10~14, A08
• 08800108663280: PathLoc - TM L25XW11, H10~14, A04
• 08800108663273: PathLoc - TM L25XW11, H10~14, A00
• 08800108663266: PathLoc - TM L25XW11, H08~12, A20
• 08800108663259: PathLoc - TM L25XW11, H08~12, A15
• 08800108663242: PathLoc - TM L25XW11, H08~12, A12
• 08800108663235: PathLoc - TM L25XW11, H08~12, A08
• 08800108663228: PathLoc - TM L25XW11, H08~12, A04
• 08800108663211: PathLoc - TM L25XW11, H08~12, A00
• 08800108663204: PathLoc - TM L22XW11, H12~16, A20
• 08800108663198: PathLoc - TM L22XW11, H12~16, A15
• 08800108663181: PathLoc - TM L22XW11, H12~16, A12
• 08800108663174: PathLoc - TM L22XW11, H12~16, A08
• 08800108663167: PathLoc - TM L22XW11, H12~16, A04
• 08800108663150: PathLoc - TM L22XW11, H12~16, A00
• 08800108663143: PathLoc - TM L22XW11, H10~14, A20