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 CoRoent Small Interlock II System

K-Number: K170961 · 2017-06-08

ApplicantNu Vasive, Incorporated
Decision Date2017-06-08
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive CoRoent Small Interlock II System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2017-06-08 under approval number K170961. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive CoRoent Small Interlock II System?

NuVasive CoRoent Small Interlock II System is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K170961.

When was NuVasive CoRoent Small Interlock II System approved by the FDA?

NuVasive CoRoent Small Interlock II System received FDA 510(k) clearance on 2017-06-08, under approval number K170961.

What company makes NuVasive CoRoent Small Interlock II System?

NuVasive CoRoent Small Interlock II System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive CoRoent Small Interlock II System?

The FDA product code for NuVasive CoRoent Small Interlock II System is OVE.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

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: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

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.

↑