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FDA 510(k)

CastleLoc-P Anterior Cervical Plate System

K-Number: K190425 · 2019-03-21

ApplicantL&K BIOMED Co., Ltd.
Decision Date2019-03-21
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CastleLoc-P Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2019-03-21 under 510(k) number K190425. 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?

CastleLoc-P Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-03-21. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K190425.

When did CastleLoc-P Anterior Cervical Plate System receive FDA 510(k) clearance?

CastleLoc-P Anterior Cervical Plate System received FDA 510(k) clearance on 2019-03-21, under 510(k) number K190425.

Who is the listed applicant for CastleLoc-P Anterior Cervical Plate System?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing L&K BIOMED Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260840BluEX Cervical Expandable Cage SystemK261112CastleLoc-P Anterior Cervical Plate SystemK261130AccelFix Spinal Fixation SystemK260448CastleLoc Pectus Bar SystemK251940PathLoc Lumbar Plate SystemK251741PathLoc Lumbar Interbody Fusion Cage System

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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