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FDA 510(k)

NuVasive CoRoent Small Ti-C System

K-Number: K162138 · 2016-10-26

ApplicantNu Vasive, Incorporated
Decision Date2016-10-26
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive CoRoent Small Ti-C System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-10-26 under approval number K162138. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive CoRoent Small Ti-C System?

NuVasive CoRoent Small Ti-C System is a medical device that received FDA 510(k) clearance on 2016-10-26. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K162138.

When was NuVasive CoRoent Small Ti-C System approved by the FDA?

NuVasive CoRoent Small Ti-C System received FDA 510(k) clearance on 2016-10-26, under approval number K162138.

What company makes NuVasive CoRoent Small Ti-C System?

NuVasive CoRoent Small Ti-C System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive CoRoent Small Ti-C System?

The FDA product code for NuVasive CoRoent Small Ti-C System is ODP.

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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

K161014NuVasive® Reline® System K161442NuVasive® CoRoent® Small Interlock™ System K161230NuVasive Lumbar Interbody Implants K161265NuVasive® VersaTie System K153105MLX™ - Medial Lateral Expandable Lumbar Interbody System K160916CoRoent® Ti-C System

View all 79 devices →

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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.

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