510(k) Report

Devices descending from K993714

222 later devices reach Memograph Staple, Warm System through their predicates, nearest generation first.

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