F3D Corpectomy System
FDA 510(k) K202637 · Corelink, LLC
510(k) numberK202637
Submission
- Device name
- F3D Corpectomy System
- Applicant
- Corelink, LLC
St. Louis, MO, US - Received
- September 11, 2020
- Decision date
- December 23, 2020
- 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 |
| K200235 | KONG-TL VBR System, KONG-C VBR SystemMQP · Traditional | Icotec AG | 05/29/2020SE |
More from Icotec AG
| 510(k) | Device | Decision |
|---|---|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…MAX · Traditional | 12/08/2023SE |
| K231494 | CoreLink Robotic Navigation InstrumentsOLO · Traditional | 10/27/2023SE |
| K232116 | CoreLink Navigation InstrumentsOLO · Special | 08/16/2023SE |
| K230329 | F3D Interbody SystemODP · Traditional | 06/06/2023SE |
| K230880 | CoreLink Navigation InstrumentsOLO · Special | 05/02/2023SE |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant SystemOUR · Traditional | 03/21/2023SE |
| K221776 | NextGen Pedicle Screw SystemNKB · Traditional | 08/09/2022SE |
| K220973 | CoreLink Navigation InstrumentsOLO · Traditional | 06/01/2022SE |
| K211417 | F3D-C2 Cervical Stand-Alone SystemOVE · Traditional | 02/04/2022SE |
| K214059 | CoreLink Navigation InstrumentsOLO · Special | 01/19/2022SE |
Questions and answers
When was F3D Corpectomy System cleared by the FDA?
F3D Corpectomy System (K202637) received a 510(k) decision of Substantially Equivalent on December 23, 2020, 103 days after the submission was received.
What is the product code of K202637?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.