FDA 510(k) Applications Submitted by YAEL RUBIN

FDA 510(k) Number Submission Date Device Name Applicant
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.
K040612 03/08/2004 SKY BONE EXPANDER SYSTEM (SKY SYSTEM) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K200883 04/02/2020 CarboClear« Cervical Plate System Carbofix Orthopedics Ltd.
K040939 04/12/2004 SKY BONE EXPANDER SYSTEM (SKY SYSTEM) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K151010 04/15/2015 Piccolo Composite Nailing System CARBOFIX ORTHOPEDICS LTD.
K111056 04/18/2011 PICCOLO COMPOSITE NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD.
K021324 04/26/2002 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) DISCO-O-TECH MEDICAL TECHNOLOGIES, 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.
K031401 05/05/2003 FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
K071679 06/19/2007 METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K201917 07/10/2020 Piccolo Composite Proximal Tibia Plate System CarboFix Orthopedics, Ltd.
K182015 07/27/2018 Piccolo Composite« Plate System CarboFix Orthopedics Ltd.
K192214 08/15/2019 CarboClear VBR System CarboFix Orthopedics Ltd.
K102369 08/20/2010 PICCOLO COMPOSITE NAILING SYSTEM N.M.B. MEDICAL APPLICATIONS, LTD.
K032588 08/22/2003 MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
K132774 09/05/2013 PICCOLO COMPOSITE NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD.
K222874 09/22/2022 CarboClear Cervical Cage System, CarboClear Cervical VBR System CarboFix Orthpedics Ltd.
K023437 10/15/2002 FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
K964327 10/30/1996 IPU RX-2 MEDIREX, INC.
K173652 11/28/2017 Piccolo Composite Nailing System CarboFix Orthopedics Ltd.
K143496 12/09/2014 Piccolo Composite Plate System CarboFix Orthopedics Ltd.
K153536 12/10/2015 Piccolo Composite« Nailing System CARBOFIX ORTHOPEDICS, LTD.
K123810 12/11/2012 PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD.
K965013 12/16/1996 DIGISCOPE RX-2 (9 OPTION) MEDIREX, INC.


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