Last synced on 14 November 2025 at 11:06 pm

CastleLoc Pectus Bar System

Page Type
Cleared 510(K)
510(k) Number
K243357
510(k) Type
Traditional
Applicant
L&K BIOMED Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/27/2025
Days to Decision
121 days
Submission Type
Summary

CastleLoc Pectus Bar System

Page Type
Cleared 510(K)
510(k) Number
K243357
510(k) Type
Traditional
Applicant
L&K BIOMED Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/27/2025
Days to Decision
121 days
Submission Type
Summary