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FDA 510(k)

STIMULATION/DISSECTION INSTRUMENTS

K-Number: K112709 · 2012-02-09

ApplicantNu Vasive, Incorporated
Decision Date2012-02-09
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STIMULATION/DISSECTION INSTRUMENTS 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 2012-02-09 under 510(k) number K112709. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIMULATION/DISSECTION INSTRUMENTS?

STIMULATION/DISSECTION INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2012-02-09. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K112709.

When did STIMULATION/DISSECTION INSTRUMENTS receive FDA 510(k) clearance?

STIMULATION/DISSECTION INSTRUMENTS received FDA 510(k) clearance on 2012-02-09, under 510(k) number K112709.

Who is the listed applicant for STIMULATION/DISSECTION INSTRUMENTS?

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 STIMULATION/DISSECTION INSTRUMENTS?

The FDA product code for STIMULATION/DISSECTION INSTRUMENTS is ETN.

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Other records listing Nu Vasive, Incorporated as applicant

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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 SystemK230894NuVasive Modulus ALIF SystemK230989Rod Registration FrameK223181NuVasive Reline SystemK221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceK221388NuVasive Reline Cervical System

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Related Devices (Code: ETN)

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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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