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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 a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2025-04-25 under approval 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. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K250892.

When was CastleLoc Pectus Bar System approved by the FDA?

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

What company makes CastleLoc Pectus Bar System?

CastleLoc Pectus Bar System is manufactured by L&K BIOMED Co., Ltd..

What is the FDA product code for CastleLoc Pectus Bar System?

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

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: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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