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510(k) K231839

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System by L & K Biomed Co., Ltd. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2023
Date Received
June 22, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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

  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K251741 — PathLoc Lumbar Interbody Fusion Cage System (July 8, 2025)
  • 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)
  • K231841 — PathLoc SI Joint Fusion System (July 14, 2023)

Other clearances for product code KWQ

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)
  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)