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510(k) K213441

PathLoc Lumbar Interbody Fusion Cage System by L & K Biomed Co., Ltd. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2022
Date Received
October 25, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by L & K Biomed Co., Ltd.

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  • K250892 — CastleLoc Pectus Bar System (April 25, 2025)
  • K243357 — CastleLoc Pectus Bar System (February 27, 2025)
  • K242829 — BluEX Lumbar Expandable Cage System (October 23, 2024)
  • K240201 — PathLoc SI Joint Fusion System (February 23, 2024)
  • K231680 — AccelFix Lumbar Expandable Cage System (August 24, 2023)
  • K232311 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fi (August 14, 2023)
  • K231840 — CastleLoc-S Posterior Cervical Fixation System (July 20, 2023)
  • K231839 — CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (July 19, 2023)

Other clearances for product code MAX

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  • K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spac (January 23, 2026)
  • K253266 — Titanium Interbody System (January 8, 2026)
  • K253577 — IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (December 19, 2025)
  • K252610 — ZSFab Lumbar Interbody System (November 25, 2025)
  • K252351 — UniSpace® TPLIF Cage (October 28, 2025)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
  • K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion C (September 18, 2025)