510(k) Report

Devices descending from K020247

11 later devices reach Colorado 2 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211414KHEIRON Spinal Fixation SystemS.M.A.I.O20212—
+1K201659KHEIRON® Spinal Fixation SystemS.M.A.I.O202010—
+2K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+2K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+3K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+3K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+3K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—