510(k) Report

Devices descending from K183232

6 later devices reach Double ENDOBUTTON Fixation Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+2K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+2K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+2K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+3K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+3K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—