Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NuVasive Monolith Cervical Corpectomy System

K-Number: K180550 · 2018-11-20

ApplicantNu Vasive, Incorporated
Decision Date2018-11-20
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive Monolith Cervical Corpectomy System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2018-11-20 under approval number K180550. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive Monolith Cervical Corpectomy System?

NuVasive Monolith Cervical Corpectomy System is a medical device that received FDA 510(k) clearance on 2018-11-20. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K180550.

When was NuVasive Monolith Cervical Corpectomy System approved by the FDA?

NuVasive Monolith Cervical Corpectomy System received FDA 510(k) clearance on 2018-11-20, under approval number K180550.

What company makes NuVasive Monolith Cervical Corpectomy System?

NuVasive Monolith Cervical Corpectomy System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive Monolith Cervical Corpectomy System?

The FDA product code for NuVasive Monolith Cervical Corpectomy System is PLR.

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING

Other Devices by Nu Vasive, Incorporated

K162138NuVasive CoRoent Small Ti-C System K161014NuVasive® Reline® System K161442NuVasive® CoRoent® Small Interlock™ System K161230NuVasive Lumbar Interbody Implants K161265NuVasive® VersaTie System K153105MLX™ - Medial Lateral Expandable Lumbar Interbody System

View all 79 devices →

Related Devices (Code: PLR)

K152568C-VBRCardinal Spine, LLC K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. K173893TrabisColigne AG K180673Normandy VBR SystemZavation Medical Products, LLC K190284Bengal Stackable Cage SystemMedos International SARL K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑