510(k) Report

Devices descending from K101791

126 later devices reach Rosa Surgical Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K231103ROSA ONE Brain ApplicationMedtech S.A.S20230—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+10K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+11K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+12K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+13K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601