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FDA 510(k)

NIM-SPINE

K-Number: K031510 · 2003-06-18

ApplicantMedtronic Xomed
Decision Date2003-06-18
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NIM-SPINE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed. It received FDA 510(k) clearance on 2003-06-18 under 510(k) number K031510. 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 NIM-SPINE?

NIM-SPINE is a medical device that received FDA 510(k) clearance on 2003-06-18. The listed applicant is Medtronic Xomed. The 510(k) number is K031510.

When did NIM-SPINE receive FDA 510(k) clearance?

NIM-SPINE received FDA 510(k) clearance on 2003-06-18, under 510(k) number K031510.

Who is the listed applicant for NIM-SPINE?

The FDA 510(k) record lists Medtronic Xomed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIM-SPINE?

The FDA product code for NIM-SPINE is ETN.

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Related Devices (Code: ETN)

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K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc.K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)Medtronic Xomed, Inc.K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)Inomed Medizintechnik GmbHK233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S.K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLCK232888Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., Ltd.

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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