FDA 510(k) Applications Submitted by CARBOFIX ORTHOPEDICS LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K200519 03/02/2020 CarboClear« II Pedicle Screw System CarboFix Orthopedics Ltd.
K190526 03/04/2019 High V+ Bone Cement, CarboClear« Fenestrated Pedicle Screws CarboFix Orthopedics Ltd.
K210716 03/10/2021 CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments CarboFix Orthopedics Ltd.
K201251 05/11/2020 CarboClear Navigated Instruments CarboFix Orthopedics Ltd.
K201926 07/10/2020 CarboClear« Pedicle Screw System, CarboClear« II Pedicle Screw System CarboFix Orthopedics Ltd.
K182377 08/31/2018 CarboClear« Pedicle Screw System CarboFix Orthopedics Ltd.
K203317 11/10/2020 CarboClear X Pedicle Screw System CarboFix Orthopedics Ltd.
K173487 11/13/2017 CarboClear« Pedicle Screw System CarboFix Orthopedics Ltd.
K193378 12/05/2019 CarboClear Lumbar Cage System CarboFix Orthopedics Ltd.
K160002 01/04/2016 Piccolo Composite(R) Distal Volar Radius Plate System CARBOFIX ORTHOPEDICS LTD.
K130061 01/10/2013 PICCOLO COMPOSITE PLATE SYSTEM CARBOFIX ORTHOPEDICS LTD.
K120409 02/09/2012 PICCOLO COMPOSITE PLATE SYSTEM CARBOFIX ORTHOPEDICS LTD.
K170401 02/09/2017 Piccolo Composite« Plate System CarboFix Orthopedics Ltd.
K200883 04/02/2020 CarboClear« Cervical Plate System Carbofix Orthopedics Ltd.
K151010 04/15/2015 Piccolo Composite Nailing System CARBOFIX ORTHOPEDICS LTD.
K111056 04/18/2011 PICCOLO COMPOSITE NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD.
K231280 05/03/2023 CarboClear« X Pedicle Screw System; CarboClear« X Navigated Instruments; CarboClear« X Fenestrated Pedicle Screw System with High V+« Bone Cement Carbofix Orthopedics Ltd.
K182015 07/27/2018 Piccolo Composite« Plate System CarboFix Orthopedics Ltd.
K192214 08/15/2019 CarboClear VBR System CarboFix Orthopedics Ltd.
K132774 09/05/2013 PICCOLO COMPOSITE NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD.
K173652 11/28/2017 Piccolo Composite Nailing System CarboFix Orthopedics Ltd.
K143496 12/09/2014 Piccolo Composite Plate System CarboFix Orthopedics Ltd.
K123810 12/11/2012 PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD.


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