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FDA 510(k)

CastleLoc Pectus Bar System

K-Number: K250892 · 2025-04-25

ApplicantL&K BIOMED Co., Ltd.
Decision Date2025-04-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CastleLoc Pectus Bar 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 2025-04-25 under 510(k) number K250892. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CastleLoc Pectus Bar System?

CastleLoc Pectus Bar System is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K250892.

When did CastleLoc Pectus Bar System receive FDA 510(k) clearance?

CastleLoc Pectus Bar System received FDA 510(k) clearance on 2025-04-25, under 510(k) number K250892.

Who is the listed applicant for CastleLoc Pectus Bar 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 Pectus Bar System?

The FDA product code for CastleLoc Pectus Bar System is HRS.

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: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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