510(k) Report

Devices descending from K990345

46 later devices reach Rabea Device, Model Pxxxxxx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021788NBD Cement Restrictor DeviceNew Business Development, LLC20020—
+1K021719Fortitude Cement RestrictorSpinal Concepts, Inc.20026—
+1K020836Rabea Cement RestrictorSignus Medical, LLC20024—
+1K020344RPX Titanium Cemnt RestrictorSulzer Spine-Tech200233—
+1K012462Theken Large Cement RestrictorTheken Surgical,Llc20010—
+1K012278Theken Small Cement RestrictorTheken Surgical,Llc20010—
+2K060132Spinal Usa Cement Restrictor SystemSpinal USA20060—
+2K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp20050—
+2K051607Novaspine Cement Restrictor NSCRNovaspine, LLC20050—
+2K052367Scient'x Cement RestrictorScient'X20051—
+2K041583Peek Cement Restrictor X-BoxInnovasis, Inc.20040—
+2K033953Optimesh 500E Cement RestrictorSpineology, Inc.20040—
+2K031837Modification to Fortitude Cement RestrictorSpinal Concepts, Inc.20035—
+2K022615Centerpulse, Spine-Tech Division Cement RestrictorCenterpulse Spine-Tech, Inc.200232—
+3K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K131636Polarus ConnectAcumed, LLC20130—
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+4K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+4K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+4K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K160995NEOVIEW Plating SystemIn2bones Sas201624
+5K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+5K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+5K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+5K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K163589SIGN IM NailSign Fracture Care International20170—
+7K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123