510(k) Report

Devices descending from K013059

7 later devices reach Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111—
+1K023411Steelex Sternum SetAesculap, Inc.20024—
+2K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200—
+2K063603Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated20071—
+2K032468Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated20031—
+3K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L.20090—
+3K082828Suturtek 360 Degree Sternal Closure DeviceSuturtek Incorporated20080—