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FDA 510(k)

NuVasive® VersaTie™ System

K-Number: K173117 · 2017-12-07

ApplicantNuvasive, Inc.
Decision Date2017-12-07
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive® VersaTie™ System is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 2017-12-07 under 510(k) 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. The listed applicant is Nuvasive, Inc.. The 510(k) number is K173117.

When did NuVasive® VersaTie™ System receive FDA 510(k) clearance?

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

Who is the listed applicant for NuVasive® VersaTie™ System?

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

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

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

Other records listing Nuvasive, Inc. as applicant

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Related Devices (Code: OWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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