510(k) Report

Devices descending from K231479

8 later devices reach TriALTIS Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+1K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+1K253249TriALTIS™ Spine SystemMedos International SARL20251—
+1K243249TriALTIS™ Spine SystemMedos International SARL20250—
+1K233684TriALTIS™ Spine SystemMedos International SARL20234—
+2K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+2K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+2K242042TriALTIS™ Spine SystemMedos International SARL20241—