NuVasive Monolith Cervical Corpectomy System
FDA 510(k) clearance K180550 · decided 2018-11-20
Clearance details
- K-number
- K180550
- Device name
- NuVasive Monolith Cervical Corpectomy System
- Applicant
- Nu Vasive, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2018-03-01
- Decision date
- 2018-11-20
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- PLR
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant (K252822) | Atlas Spine, Inc. | 2026-07-15 |
| Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (K252560) | Atlas Spine, Inc. | 2025-11-10 |
| RIGEL™ 3DR Anterior Cervical Corpectomy System (K232481) | MiRus, LLC | 2023-10-13 |
| Galileo Vertebral Body Replacement Device (K221542) | Bright Spine | 2023-01-13 |
| MediExpand Cervical Expandable VBR System (K212126) | Cmf Medicon Surgical, Inc. | 2022-04-04 |
| CAPRI Corpectomy Cage System (K211320) | K2m, Inc. | 2022-02-24 |
| Galileo Vertebral Body Replacement Device (K192145) | Bright Spine | 2020-04-21 |
| NEXXT MATRIXX System (K193412) | Nexxt Spine, LLC | 2020-02-24 |
| Bengal Stackable Cage System (K190284) | Medos International SARL | 2019-12-20 |
| ALTA Anterior Cervical Corpectomy System (K190426) | Astura Medical, LLC | 2019-10-24 |
| Omnia Medical VBR (K191778) | Omnia Medical, LLC | 2019-08-28 |
| Normandy VBR System (K191423) | Zavation Medical Products, LLC | 2019-08-06 |
Recalls involving this device
No recalls on record reference this clearance.