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CarboFix Orthopedics, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
31
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1991-2016Class IIPiccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures May 10, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K243106CarboClear® Hybrid Pedicle Screw SystemNovember 5, 2024
K233793CarboClear® X Pedicle Screw SystemAugust 1, 2024
K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® HybriApril 25, 2024
K233989CarboClear® Posterior Cervical Screw SystemMarch 27, 2024
K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsJanuary 10, 2024
K232341CarboClear® Pedicle Screw SystemOctober 10, 2023
K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated PJuly 3, 2023
K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsApril 6, 2021
K203317CarboClear X Pedicle Screw SystemNovember 25, 2020
K201917Piccolo Composite Proximal Tibia Plate SystemOctober 8, 2020
K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemAugust 7, 2020
K201251CarboClear Navigated InstrumentsAugust 5, 2020
K200883CarboClear® Cervical Plate SystemJune 4, 2020
K200519CarboClear® II Pedicle Screw SystemApril 30, 2020
K193378CarboClear Lumbar Cage SystemMarch 2, 2020
K192214CarboClear VBR SystemOctober 11, 2019
K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsSeptember 19, 2019
K182015Piccolo Composite® Plate SystemOctober 11, 2018
K182377CarboClear® Pedicle Screw SystemSeptember 27, 2018
K173487CarboClear® Pedicle Screw SystemJuly 18, 2018