FDA 510(k)

NuVasive® VersaTie System

K-Number: K173117 · 2017-12-07

Decision Date2017-12-07

Product CodeOWI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NuVasive® VersaTie System is a medical device manufactured by Nuvasive, Inc.. It received FDA 510(k) clearance on 2017-12-07 under approval number K173117. 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 NuVasive® VersaTie System?

NuVasive® VersaTie System is a medical device that received FDA 510(k) clearance on 2017-12-07. It is manufactured by Nuvasive, Inc.. The 510(k) number is K173117.

When was NuVasive® VersaTie System approved by the FDA?

NuVasive® VersaTie System received FDA 510(k) clearance on 2017-12-07, under approval number K173117.

What company makes NuVasive® VersaTie System?

NuVasive® VersaTie System is manufactured by Nuvasive, Inc..

What is the FDA product code for NuVasive® VersaTie System?

The FDA product code for NuVasive® VersaTie System is OWI.

Other Devices by Nuvasive, Inc.

K211757Simplify Disc K223731NuVasive Modulus-C Interbody System K240507NuVasive AttraX Scaffold PMA P100012Prosthesis, intervertebral disc PMA P200022Prosthesis, intervertebral disc

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. K172417SILC® Fixation SystemGlobus Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.