510(k) Report

Devices descending from K250646

3 later devices reach Impact PEEK Union Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+1K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+2K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—