510(k) Report

Devices descending from K120819

206 later devices reach Stalif C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+9K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+9K223326Axiom PSR SystemRestor3D202301
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—