510(k) Report

Devices descending from K222110

8 later devices reach Mariner RDX System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+1K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+1K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+1K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+2K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+2K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+2K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+2K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—