510(k) Report

Devices descending from K052576

28 later devices reach Sbi Autofix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+1K163148BePOD® Foot ScrewsFournitures Hospitalieres Industrie20170—
+1K171407ExsoMed ArcPhix and ExsoMed ArrowPhixExsomed Holding Company, LLC20170—
+1K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+1K170012Foot and Hand MotionNewclip Technics20170—
+1K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617—
+1K143596Miniars ScrewsOvermed Srl.20160—
+1K150871ForeFoot STP SystemTornier, Inc.20150—
+1K143229Nexis osteosynthesis compressive screwsNovastep20153—
+1K131920Stabilization ScrewIn2bones Sas2014183
+2K254280F.A.S.T ScrewSteps Ortho20260—
+2K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+2K223468Nexis® compressive screwsNovastep20230—
+2K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+2K230397Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda.20230—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+2K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+2K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+2K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—