Solidity Vertebral Body Replacement
FDA 510(k) K181921 · Ulrich Medical USA
510(k) numberK181921
Submission
- Device name
- Solidity Vertebral Body Replacement
- Applicant
- Ulrich Medical USA
Chesterfield, MO, US - Received
- July 18, 2018
- Decision date
- November 16, 2018
- 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 |
|---|---|---|
| K252087 | Navigation Module of the Cortium® SystemOLO · Traditional | 02/03/2026SE |
| K251719 | Momentum® Posterior Spinal Fixation SystemNKB · Special | 07/01/2025SE |
| K241396 | uCerv Flux-C 3D Porous Titanium Cervical InterbodyODP · Special | 05/23/2024SE |
| K240515 | uNion® MAX Cervical Plate SystemKWQ · Special | 03/18/2024SE |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…PML · Traditional | 10/20/2023SE |
| K230614 | CortiumNKG · Traditional | 05/02/2023SE |
| K223274 | Momentum® MIS Posterior Spinal Fixation SystemNKB · Special | 11/28/2022SE |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical InterbodyODP · Traditional | 08/19/2022SE |
| K200845 | Navigation Module of the Momentum SystemOLO · Traditional | 09/10/2020SE |
| K191932 | Momentum Posterior Spinal Fixation SystemNKB · Traditional | 10/02/2019SE |
Questions and answers
When was Solidity Vertebral Body Replacement cleared by the FDA?
Solidity Vertebral Body Replacement (K181921) received a 510(k) decision of Substantially Equivalent on November 16, 2018, 121 days after the submission was received.
What is the product code of K181921?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.