510(k) Report

Devices descending from K001801

128 later devices reach Steathstation Treatment Guidance Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K231103ROSA ONE Brain ApplicationMedtech S.A.S20230—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+11K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+12K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+13K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+14K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601