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510(k) K261112

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2026
Date Received
April 3, 2026
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.

  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K260448 — CastleLoc Pectus Bar System (March 19, 2026)
  • 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)

Other clearances for product code KWQ

  • K252776 — ARIES Anterior Cervical Plate Systems (May 14, 2026)
  • K260570 — corra™ cervical plating system (April 22, 2026)
  • K260697 — VyPlate™ Anterior Cervical Plate System (March 27, 2026)
  • 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)