510(k) Report

Devices descending from K902307

226 later devices reach Shaw II Hemostatic Surgery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+10K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+10K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+10K211843PolyLock Plating SystemFusion Orthopedics20220—
+10K213214Xpert WristNewclip Technics20210—
+10K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+10K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+10K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+10K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+10K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+10K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+11K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+11K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+11K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+11K201149CoLink Plating SystemIn2bones USA, LLC20200—
+11K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+11K192592Axis Plating SystemExtremity Medical, LLC20190—
+11K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+12K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+12K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+12K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+12K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+13K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+13K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123