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L&K BIOMED Co., Ltd. FDA Approvals

0 new drug approvals and 21 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
BluEX Cervical Expandable Cage System510(k)Aug 18, 2026Orthopedic
BluEX Cervical Expandable Cage System510(k)May 16, 2026Orthopedic
CastleLoc-P Anterior Cervical Plate System510(k)May 6, 2026Orthopedic
AccelFix Spinal Fixation System510(k)May 5, 2026Orthopedic
CastleLoc Pectus Bar System510(k)Mar 19, 2026Orthopedic
PathLoc Lumbar Plate System510(k)Mar 3, 2026Orthopedic
PathLoc Lumbar Interbody Fusion Cage System510(k)Jul 8, 2025Orthopedic
CastleLoc Pectus Bar System510(k)Apr 25, 2025Orthopedic
CastleLoc Pectus Bar System510(k)Feb 27, 2025Orthopedic
BluEX Lumbar Expandable Cage System510(k)Oct 23, 2024Orthopedic
PathLoc SI Joint Fusion System510(k)Feb 23, 2024Orthopedic
AccelFix Lumbar Expandable Cage System510(k)Aug 24, 2023Orthopedic
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System510(k)Aug 14, 2023Orthopedic
CastleLoc-S Posterior Cervical Fixation System510(k)Jul 20, 2023Orthopedic
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System510(k)Jul 19, 2023Orthopedic
PathLoc SI Joint Fusion System510(k)Jul 14, 2023Orthopedic
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.510(k)Jun 27, 2023Orthopedic
LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System510(k)Feb 28, 2023Orthopedic
PathLoc-TA Expandable Lumbar Cage System510(k)Jan 13, 2023Orthopedic
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.510(k)Dec 23, 2022Orthopedic
PathLoc Lumbar Interbody Fusion Cage System510(k)Mar 9, 2022Orthopedic

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