510(k) Report

Devices descending from K072226

812 later devices reach Impix Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+10K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+10K192897icotec Cervical CageIcotec AG20201—
+11K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+11K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+11K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—