510(k) Report

Devices descending from K033804

7 later devices reach Bioanchor with Disposable Driver through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042778Bioanchor with Disposable Driver, Preloaded with One #2 Herculine SutureLinvatec Corp.200461
+2K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+2K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+3K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+3K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+3K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+4K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—