510(k) Report

Devices descending from K060753

100 later devices reach Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080520Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with…Siam Sempermed Corp., Ltd.200897—
+1K070639Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer CoatingSiam Sempermed Corp., Ltd.20071—
+2K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc.20160—
+2K111134Non-Sterile, Powder-Free Nitrile Examination Glove, Blue, Tested for Use with…Siem Aempemed Corp., Ltd.20120—
+2K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+2K083755Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated…Siam Sempermed Corp., Ltd.200916—
+3K182241Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with…Sri Trang Gloves (Thailand) Co., Ltd.20198—
+3K171378Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy…Semperit Investments Asia Pte, Ltd.20173—
+3K121549Non-Sterile, Powder-Free Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd.20121—
+3K122363Non-Sterile, Powder Free Nitrile Examination Gloves, BlueSiam Sempermed Corp., Ltd.20120—
+3K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+4K223903Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with…Semperit Investments Asia Pte, Ltd.20232—
+4K200072KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation20203—
+4K193581Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs -…Sri Trang Gloves (Thailand) Public Company Limited20203—
+4K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+4K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+4K142685Nitrile Examination Gloves with Aloe & Vitamin E, Powder- FreeSiam Sempermed Corp., Ltd.20150—
+4K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+4K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+4K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+4K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+5K233990Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and…Shandong Xingyu Gloves Co., Ltd.20240—
+5K233520Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with…Anhui Powerguard Technology Co., Ltd.20240—
+5K231435KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation20230—
+5K231021KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation20230—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K203236Rhino Health Non-Sterile, Powder-free Nitrile Exam GloveRhino Health, Inc.20212—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K202416Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the…Kimberly Clark Corporation20200—
+5K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+5K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+5K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+5K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+5K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+5K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+6K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+6K221082Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use…Rhino Health, Inc.20221—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K202307Activ FuseNewclip Technics20200—
+6K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+6K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K223859Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with…Rhino Health, Inc.20230—
+7K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+7K172886Breakaway Screw SystemParagon 2820174—
+7K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+7K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+7K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+8K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+8K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+8K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+8K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+8K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+9K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+9K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+9K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K192592Axis Plating SystemExtremity Medical, LLC20190—
+9K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+10K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+10K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+10K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+10K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+11K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+11K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+11K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+12K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+13K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—