CarboClear® Posterior Cervical Screw System
FDA 510(k) K233989 · CarboFix Orthopedics , Ltd.
510(k) numberK233989
Submission
- Device name
- CarboClear® Posterior Cervical Screw System
- Applicant
- CarboFix Orthopedics , Ltd.
Herzeliya, IL - Received
- December 18, 2023
- Decision date
- March 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKG – Posterior Cervical Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3075
- Specialty
- Orthopedic
- Implant
- Yes
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following…
Other 510(k)s with product code NKG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsNKG · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/02/2026SE |
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…NKG · Traditional | CarboFix Orthopedics , Ltd. | 03/16/2026SE |
| K254165 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 01/21/2026SE |
| K252327 | CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG · Traditional | Icotec AG | 11/12/2025SE |
| K253129 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 10/24/2025SE |
| K251725 | ANAX OCT Spinal SystemNKG · Special | Cg Medtech Co., Ltd. | 06/25/2025SE |
| K250866 | Sovereign Posterior Cervical SystemNKG · Traditional | Met One Technologies, LLC | 05/20/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | Signature Orthopaedics Pty, Ltd. | 05/13/2025SE |
| K250332 | Virage® OCT Spinal Fixation SystemNKG · Traditional | Highridge Medical, LLC | 04/04/2025SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | MiRus, LLC | 11/19/2024SE |
More from MiRus, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…NKG · Traditional | 03/16/2026SE |
| K243106 | CarboClear® Hybrid Pedicle Screw SystemNKB · Traditional | 11/05/2024SE |
| K233793 | CarboClear® X Pedicle Screw SystemNKB · Traditional | 08/01/2024SE |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…NKB · Special | 04/25/2024SE |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsNKB · Special | 01/10/2024SE |
| K232341 | CarboClear® Pedicle Screw SystemNKB · Traditional | 10/10/2023SE |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…NKB · Traditional | 07/03/2023SE |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsNKB · Special | 04/06/2021SE |
| K203317 | CarboClear X Pedicle Screw SystemNKB · Special | 11/25/2020SE |
| K201917 | Piccolo Composite Proximal Tibia Plate SystemHRS · Traditional | 10/08/2020SE |
Questions and answers
When was CarboClear® Posterior Cervical Screw System cleared by the FDA?
CarboClear® Posterior Cervical Screw System (K233989) received a 510(k) decision of Substantially Equivalent on March 27, 2024, 100 days after the submission was received.
What is the product code of K233989?
The FDA product code is NKG – Posterior Cervical Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3075.