510(k) Report

Devices descending from K161231

2 later devices reach Facilis™ Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190600ORION Spinal SystemOrion Biotech, Inc.20200—
+1K191494Facilis™ Spinal SystemBaui Biotech Co., Ltd.20190—