FDA 510(k)

COROENT STERILE IMPLANTS SYSTEM

K-Number: K132601 · 2013-12-24

Decision Date2013-12-24

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COROENT STERILE IMPLANTS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2013-12-24 under 510(k) number K132601. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COROENT STERILE IMPLANTS SYSTEM?

COROENT STERILE IMPLANTS SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-24. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K132601.

When did COROENT STERILE IMPLANTS SYSTEM receive FDA 510(k) clearance?

COROENT STERILE IMPLANTS SYSTEM received FDA 510(k) clearance on 2013-12-24, under 510(k) number K132601.

Who is the listed applicant for COROENT STERILE IMPLANTS SYSTEM?

The FDA 510(k) record lists Nu Vasive, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COROENT STERILE IMPLANTS SYSTEM?

The FDA product code for COROENT STERILE IMPLANTS SYSTEM is MAX.

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Other records listing Nu Vasive, Incorporated as applicant

K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System K230894NuVasive Modulus ALIF System K230989Rod Registration Frame K223181NuVasive Reline System K221751NuVasive Cohere ALIF System Intervertebral Body Fusion Device K221388NuVasive Reline Cervical System

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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.