510(k) Report

Devices descending from K060556

128 later devices reach Brigit Surgical Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K231103ROSA ONE Brain ApplicationMedtech S.A.S20230—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+12K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+13K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+14K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+15K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601