510(k) Report

Devices descending from K220374

9 later devices reach EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231479TriALTIS Spine SystemMedos International SARL20238—
+2K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+2K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+2K253249TriALTIS™ Spine SystemMedos International SARL20251—
+2K243249TriALTIS™ Spine SystemMedos International SARL20250—
+2K233684TriALTIS™ Spine SystemMedos International SARL20234—
+3K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K242042TriALTIS™ Spine SystemMedos International SARL20241—