510(k) Report

Devices descending from K200245

12 later devices reach EXPEDIUM® Spine System; EXPEDIUM VERSE® 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—
+1K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+1K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+2K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+2K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+2K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+2K231479TriALTIS Spine SystemMedos International SARL20238—
+3K243249TriALTIS™ Spine SystemMedos International SARL20250—
+3K233684TriALTIS™ Spine SystemMedos International SARL20234—
+4K242042TriALTIS™ Spine SystemMedos International SARL20241—