510(k) Report

Devices descending from K180377

7 later devices reach Fracture and Correction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+1K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+1K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+1K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+1K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+2K254280F.A.S.T ScrewSteps Ortho20260—
+2K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—