510(k) Report

Devices descending from K192356

2 later devices reach Airlock Centrolock Osteosynthesis Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+2K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—