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FDA 510(k)

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System

K-Number: K231839 · 2023-07-19

ApplicantL&K BIOMED Co., Ltd.
Decision Date2023-07-19
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2023-07-19 under approval number K231839. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System?

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2023-07-19. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K231839.

When was CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System approved by the FDA?

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System received FDA 510(k) clearance on 2023-07-19, under approval number K231839.

What company makes CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System?

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System is manufactured by L&K BIOMED Co., Ltd..

What is the FDA product code for CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System?

The FDA product code for CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System is KWQ.

Related Clinical Trials

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

K153656PathLoc-SI Joint Fusion System K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System K162801CastleLoc Spinal Fixation System K161766PathLoc-L MIS Spinal System K153439PathLoc-C Posterior Cervical Fixation System K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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