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510(k) K260448

CastleLoc Pectus Bar System by L&K BIOMED Co., Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2026
Date Received
February 11, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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

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  • 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)

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