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FDA 510(k)

NILE Alternative Fixation Spinal System

K-Number: K160208 · 2016-03-18

ApplicantK2m, Inc.
Decision Date2016-03-18
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NILE Alternative Fixation Spinal System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2016-03-18 under approval number K160208. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NILE Alternative Fixation Spinal System?

NILE Alternative Fixation Spinal System is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by K2m, Inc.. The 510(k) number is K160208.

When was NILE Alternative Fixation Spinal System approved by the FDA?

NILE Alternative Fixation Spinal System received FDA 510(k) clearance on 2016-03-18, under approval number K160208.

What company makes NILE Alternative Fixation Spinal System?

NILE Alternative Fixation Spinal System is manufactured by K2m, Inc..

What is the FDA product code for NILE Alternative Fixation Spinal System?

The FDA product code for NILE Alternative Fixation Spinal System is OWI.

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Related PubMed Literature

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Other Devices by K2m, Inc.

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Related Devices (Code: OWI)

K160698LigaPASSMedicrea International SA K161267Response BandLoc Spinal FixationOrthoPediatrics Corp. K161265NuVasive® VersaTie SystemNu Vasive, Incorporated K153348JAZZ LOCKImplanet, S.A. K173117NuVasive® VersaTie™ SystemNuvasive, Inc. K172417SILC® Fixation SystemGlobus Medical, 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.

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