510(k) Report

Devices descending from K112496

604 later devices reach Pioneer Crossfuse II Ibf/VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+10K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—