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FDA 510(k)

NILE Proximal Fixation Spinal System

K-Number: K161332 · 2017-04-05

ApplicantK2m, Inc.
Decision Date2017-04-05
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NILE Proximal Fixation Spinal System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2017-04-05 under approval number K161332. 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 Proximal Fixation Spinal System?

NILE Proximal Fixation Spinal System is a medical device that received FDA 510(k) clearance on 2017-04-05. It is manufactured by K2m, Inc.. The 510(k) number is K161332.

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

NILE Proximal Fixation Spinal System received FDA 510(k) clearance on 2017-04-05, under approval number K161332.

What company makes NILE Proximal Fixation Spinal System?

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

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by K2m, Inc.

K162664Pyrenees Cervical Plate System K162264Cascadia Interbody System K161028K2M Growing Spine System K160208NILE Alternative Fixation Spinal System K172009Cascadia Interbody System K171832Range/Denali/Mesa Spinal System

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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. K160208NILE Alternative Fixation Spinal SystemK2m, Inc. K173117NuVasive® VersaTie™ SystemNuvasive, 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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