510(k) Report

Devices descending from K914812

3 later devices reach K-Cap-E, Sterile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022597K-FIXNew Deal, S.A.20022—
+2K203698CoLink Sfx Implant SystemIn2bones USA, LLC20211—
+3K231905Electro-Spec Steri-CapsElectro-Spec, Inc.20230—