CastleLoc-P Anterior Cervical Plate System
K-Number: K261112 · 2026-05-06
ApplicantL&K BIOMED Co., Ltd.
Decision Date2026-05-06
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CastleLoc-P Anterior Cervical Plate System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2026-05-06 under approval number K261112. 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 2026-05-06. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K261112.
When was CastleLoc-P Anterior Cervical Plate System approved by the FDA?
CastleLoc-P Anterior Cervical Plate System received FDA 510(k) clearance on 2026-05-06, under approval number K261112.
What company makes CastleLoc-P Anterior Cervical Plate System?
CastleLoc-P Anterior Cervical Plate System is manufactured by L&K BIOMED Co., Ltd..
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.
Other Devices by L&K BIOMED Co., Ltd.
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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.