CarboClear VBR System
FDA 510(k) K192214 · CarboFix Orthopedics , Ltd.
510(k) numberK192214
Submission
- Device name
- CarboClear VBR System
- Applicant
- CarboFix Orthopedics , Ltd.
Herzeliya, IL - Received
- August 15, 2019
- Decision date
- October 11, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
More from Corelink, 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 |
| K233989 | CarboClear® Posterior Cervical Screw SystemNKG · Traditional | 03/27/2024SE |
| 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 |
Questions and answers
When was CarboClear VBR System cleared by the FDA?
CarboClear VBR System (K192214) received a 510(k) decision of Substantially Equivalent on October 11, 2019, 57 days after the submission was received.
What is the product code of K192214?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.