510(k) Report

Devices descending from K222515

2 later devices reach FaSet Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+2K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—