NuVasive Monolith Cervical Corpectomy System
FDA 510(k) K180550 · Nu Vasive, Incorporated
510(k) numberK180550
Submission
- Device name
- NuVasive Monolith Cervical Corpectomy System
- Applicant
- Nu Vasive, Incorporated
San Diego, CA, US - Received
- March 1, 2018
- Decision date
- November 20, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLR – Spinal Vertebral Body Replacement Device - Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Vertebral body replacement in the cervical spine.
Other 510(k)s with product code PLR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | Atlas Spine, Inc. | 07/15/2026SE |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | Atlas Spine, Inc. | 11/10/2025SE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional | MiRus, LLC | 10/13/2023SE |
| K221542 | Galileo Vertebral Body Replacement DevicePLR · Special | Bright Spine | 01/13/2023SE |
| K212126 | MediExpand Cervical Expandable VBR SystemPLR · Traditional | Cmf Medicon Surgical, Inc. | 04/04/2022SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | K2m, Inc. | 02/24/2022SE |
| K192145 | Galileo Vertebral Body Replacement DevicePLR · Traditional | Bright Spine | 04/21/2020SE |
| K193412 | NEXXT MATRIXX SystemPLR · Traditional | Nexxt Spine, LLC | 02/24/2020SE |
| K190284 | Bengal Stackable Cage SystemPLR · Traditional | Medos International SARL | 12/20/2019SE |
| K190426 | ALTA Anterior Cervical Corpectomy SystemPLR · Traditional | Astura Medical, LLC | 10/24/2019SE |
More from Astura Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…ODP · Special | 07/11/2023SE |
| K230894 | NuVasive Modulus ALIF SystemOVD · Traditional | 06/16/2023SE |
| K230989 | Rod Registration FrameOLO · Special | 05/05/2023SE |
| K223181 | NuVasive Reline SystemNKB · Traditional | 01/11/2023SE |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceOVD · Traditional | 10/21/2022SE |
| K221388 | NuVasive Reline Cervical SystemNKG · Traditional | 09/09/2022SE |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX · Traditional | 06/21/2022SE |
| K213654 | NuVasive Reline Cervical SystemNKG · Traditional | 02/23/2022SE |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…MAX · Traditional | 12/23/2021SE |
| K212446 | NuVasive Anterior Cervical Plate SystemsKWQ · Traditional | 11/03/2021SE |
Questions and answers
When was NuVasive Monolith Cervical Corpectomy System cleared by the FDA?
NuVasive Monolith Cervical Corpectomy System (K180550) received a 510(k) decision of Substantially Equivalent on November 20, 2018, 264 days after the submission was received.
What is the product code of K180550?
The FDA product code is PLR – Spinal Vertebral Body Replacement Device - Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3060.