510(k) Report

Devices descending from K163156

8 later devices reach SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240415Newclip Patient-matched instrumentation non sterile PSINewclip Technics20242—
+1K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics20233—
+1K220717RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC20223—
+2K241811MedCAD® AccuStride™ SystemMedcad20252—
+2K243912Newclip Patient-matched instrumentation non sterile PSINewclip Technics20251—
+3K252064MedCAD® AccuStride™ SystemMedcad20260—
+3K251709MedCAD® AccuStride™ SystemMedcad20250—
+3K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics20250—