510(k) Report

Devices descending from K191057

5 later devices reach Park's Pectus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251050Pectus Versa SystemGm Dos Reis Industria E Comercio20250—
+1K242751ARIX Pectus Bar SystemJeil Medical Corporation20250—
+1K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+1K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+2K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—