FDA 510(k) Applications Submitted by HILA WACHSLER-AVRAHAMI

FDA 510(k) Number Submission Date Device Name Applicant
K060300 02/06/2006 CONFIDENCE HIGH VISCOSITY BONE CEMENT DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K100497 02/22/2010 QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) N.M.B. MEDICAL APPLICATIONS, LTD.
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.
K240846 03/27/2024 CarboClear« Hybrid Pedicle Screw System; CarboClear« Hybrid Navigated Instruments; CarboClear« Hybrid Fenestrated Pedicle Screw System and High V+« Bone Cement; CarboClear« X Fenestrated Pedicle Screw System and High V+« Bone Cement CarboFix Orthopedics Ltd.
K030972 03/28/2003 FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) DISC-O-TECH MEDICAL TECHNOLOGIES, 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.
K032730 09/03/2003 FIXION HIP SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K102597 09/10/2010 PICCOLO COMPOSITE PLATE SYSTEM N.M.B. MEDICAL APPLICATIONS, LTD.
K243106 09/30/2024 CarboClear« Hybrid 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.
K233793 11/28/2023 CarboClear« X Pedicle Screw System CarboFix Orthopedics Ltd.
K193378 12/05/2019 CarboClear Lumbar Cage System CarboFix Orthopedics Ltd.
K233944 12/14/2023 CarboClear« X Pedicle Screw System; CarboClear« X Navigated Instruments CarboFix Orthopedics, Ltd.
K203683 12/17/2020 CarboClear Lumbar Cage System CarboFix Orthpedics Ltd.


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