Medical Device Manufacturer · IL , Herzliya

CarboFix Orthopedics , Ltd. - FDA 510(k) Cleared Devices

32 submissions · 32 cleared · Since 2011

Recent clearances: CarboClear® Posterior Cervical Screw System, CarboClear® Hybrid Pedicle Screw System, CarboClear® X Pedicle Screw System

32
Total
32
Cleared
0
Denied

FDA 510(k) Regulatory Record - CarboFix Orthopedics , Ltd. Orthopedic ✕

32 devices
1-12 of 32
Cleared Mar 16, 2026
CarboClear® Posterior Cervical Screw System
K254045 · NKG
Orthopedic · 89d
Cleared Nov 05, 2024
CarboClear® Hybrid Pedicle Screw System
K243106 · NKB
Orthopedic · 36d
Cleared Aug 01, 2024
CarboClear® X Pedicle Screw System
K233793 · NKB
Orthopedic · 247d
Cleared Apr 25, 2024
CarboClear® Hybrid Pedicle Screw System
K240846 · NKB
Orthopedic · 29d
Cleared Mar 27, 2024
CarboClear® Posterior Cervical Screw System
K233989 · NKG
Orthopedic · 100d
Cleared Jan 10, 2024
CarboClear® X Pedicle Screw System
K233944 · NKB
Orthopedic · 27d
Cleared CT Oct 10, 2023
CarboClear® Pedicle Screw System
K232341 · NKB
Orthopedic · 67d
Cleared Jul 03, 2023
CarboClear® X Pedicle Screw System
K231280 · NKB
Orthopedic · 61d
Cleared Apr 06, 2021
CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
K210716 · NKB
Orthopedic · 27d
Cleared Nov 25, 2020
CarboClear X Pedicle Screw System
K203317 · NKB
Orthopedic · 15d
Cleared Oct 08, 2020
Piccolo Composite Proximal Tibia Plate System
K201917 · HRS
Orthopedic · 90d
Cleared Aug 07, 2020
CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System
K201926 · NKB
Orthopedic · 28d
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