Chrysalis Intelligence · Sponsors · CarboFix Orthopedics , Ltd.

CarboFix Orthopedics , Ltd.

Herzeliya, IL · 16 510(k) clearances

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Total clearances
16
2020-03-02 → 2026-03-16
Last 12 months
1
Product codes
6
Most recent
2026-03-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 10 2024-11-05
NKG Posterior Cervical Screw System Class II Orthopedic 2 2026-03-16
HRS Plate, Fixation, Bone Class II Orthopedic 1 2020-10-08
OLO Orthopedic Stereotaxic Instrument Class II Neurology 1 2020-08-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Class II Orthopedic 1 2020-06-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 1 2020-03-02
Filings

All 510(k) clearances (16)

Date K-number Device Code Class Specialty
2026-03-16 K254045 CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System NKG Class II Orthopedic
2024-11-05 K243106 CarboClear® Hybrid Pedicle Screw System NKB Class II Orthopedic
2024-08-01 K233793 CarboClear® X Pedicle Screw System NKB Class II Orthopedic
2024-04-25 K240846 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 NKB Class II Orthopedic
2024-03-27 K233989 CarboClear® Posterior Cervical Screw System NKG Class II Orthopedic
2024-01-10 K233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments NKB Class II Orthopedic
2023-10-10 K232341 CarboClear® Pedicle Screw System NKB Class II Orthopedic
2023-07-03 K231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement NKB Class II Orthopedic
2021-04-06 K210716 CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments NKB Class II Orthopedic
2020-11-25 K203317 CarboClear X Pedicle Screw System NKB Class II Orthopedic
2020-10-08 K201917 Piccolo Composite Proximal Tibia Plate System HRS Class II Orthopedic
2020-08-07 K201926 CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System NKB Class II Orthopedic
2020-08-05 K201251 CarboClear Navigated Instruments OLO Class II Neurology
2020-06-04 K200883 CarboClear® Cervical Plate System KWQ Class II Orthopedic
2020-04-30 K200519 CarboClear® II Pedicle Screw System NKB Class II Orthopedic
2020-03-02 K193378 CarboClear Lumbar Cage System MAX Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence