MQP · Spinal Vertebral Body Replacement Device
Orthopedic · 21 CFR 888.3060 · Class 2
Overview
| Product Code | MQP |
|---|---|
| Device Name | Spinal Vertebral Body Replacement Device |
| Regulation | 21 CFR 888.3060 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 277)
Showing 20 most recent of 277 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253158 | VyBrate VBR System | Vy Spine, LLC | Jan 7, 2026 | SESE |
| K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | Nov 7, 2024 | SESE |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | Apr 4, 2024 | SESE |
| K233359 | DOMINION Expandable Corpectomy System | Astura Medical | Mar 8, 2024 | SESE |
| K231134 | VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. | Feb 13, 2024 | SESE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | Oct 6, 2023 | SESE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC | Oct 6, 2022 | SESE |
| K202637 | F3D Corpectomy System | Corelink, LLC | Dec 23, 2020 | SESE |
| K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | May 29, 2020 | SESE |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | Feb 26, 2020 | SESE |
| K192117 | Small VBR | Ulrich GmbH & Co. KG | Nov 1, 2019 | SESE |
| K190349 | MediExpand TL Expandable VBR System | Cmf Medicon Surgical, Inc. | Oct 24, 2019 | SESE |
| K192214 | CarboClear VBR System | CarboFix Orthopedics , Ltd. | Oct 11, 2019 | SESE |
| K183054 | SYNMESH System | Depuy Synthes Spine | May 23, 2019 | SESE |
| K190147 | COLOSSEUM Mesh | Globus Medical, Inc. | May 8, 2019 | SESE |
| K183197 | PYRAMESH Implant System | Medtronic Sofamor Danek USA, Inc. | Apr 4, 2019 | SESE |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | Feb 22, 2019 | SESE |
| K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | Jan 16, 2019 | SESE |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2m, LLC | Nov 28, 2018 | SESE |
| K181921 | Solidity Vertebral Body Replacement | Ulrich Medical USA | Nov 16, 2018 | SESE |
Top Applicants
- Medtronic Sofamor Danek — 24 clearances
- Globus Medical, Inc. — 11 clearances
- Spine Wave, Inc. — 10 clearances
- Interpore Cross Intl. — 10 clearances
- Stryker Spine — 8 clearances
