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FDA 510(k)

NuVasive® VersaTie System

K-Number: K161265 · 2016-07-15

ApplicantNu Vasive, Incorporated
Decision Date2016-07-15
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 Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161265. 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 2016-07-15. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K161265.

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

NuVasive® VersaTie System received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161265.

Who is the listed applicant for NuVasive® VersaTie System?

The FDA 510(k) record lists Nu Vasive, Incorporated 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 Nu Vasive, Incorporated as applicant

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.

K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody SystemK230894NuVasive Modulus ALIF SystemK230989Rod Registration FrameK223181NuVasive Reline SystemK221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceK221388NuVasive Reline Cervical System

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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.

K261374LigaPASS™ SystemMedicrea International S.A.SK253615Invictus Bands SystemAlphatec Spine, Inc.K222097OLYMPIC Deformity Band SystemAstura MedicalK230565HILINE™ Fixation SystemGlobus Medical, Inc.K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SAK211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, 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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