510(k) Report

Devices descending from K151511

109 later devices reach ROSA Spine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+9K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+10K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+11K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+12K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601