KONG®-TL VBR System and KONG® C VBR System
FDA 510(k) K232790 · Icotec AG
510(k) numberK232790
Submission
- Device name
- KONG®-TL VBR System and KONG® C VBR System
- Applicant
- Icotec AG
9450 Altstaetten (Sg), CH - Received
- September 11, 2023
- Decision date
- April 4, 2024
- 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 |
| 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 |
| K200235 | KONG-TL VBR System, KONG-C VBR SystemMQP · Traditional | Icotec AG | 05/29/2020SE |
More from Icotec AG
| 510(k) | Device | Decision |
|---|---|---|
| K252327 | CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG · Traditional | 11/12/2025SE |
| K242900 | VADER® Pedicle System and VADER®one Pedicle SystemNKB · Traditional | 02/27/2025SE |
| K233215 | icotec Anterior Cervical Plate SystemKWQ · Traditional | 05/17/2024SE |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…MAX · Traditional | 04/05/2024SE |
| K232628 | VADER® Pedicle SystemNKB · Traditional | 02/26/2024SE |
| K230861 | VADER® Pedicle System Navigated InstrumentsOLO · Traditional | 06/27/2023SE |
| K222789 | VADER® Pedicle System, G21 CementPML · Traditional | 01/09/2023SE |
| K201587 | icotec Anterior Cervical Plate SystemKWQ · Traditional | 10/15/2020SE |
| K200596 | G21 Cement, VADER® Pedicle SystemPML · Traditional | 10/13/2020SE |
| K200235 | KONG-TL VBR System, KONG-C VBR SystemMQP · Traditional | 05/29/2020SE |
Questions and answers
When was KONG®-TL VBR System and KONG® C VBR System cleared by the FDA?
KONG®-TL VBR System and KONG® C VBR System (K232790) received a 510(k) decision of Substantially Equivalent on April 4, 2024, 206 days after the submission was received.
What is the product code of K232790?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.