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FDA 510(k)

Sniper (R) Spine System

K-Number: K160003 · 2016-02-26

ApplicantSpine Wave, Inc.
Decision Date2016-02-26
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sniper (R) Spine System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2016-02-26 under approval number K160003. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sniper (R) Spine System?

Sniper (R) Spine System is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Spine Wave, Inc.. The 510(k) number is K160003.

When was Sniper (R) Spine System approved by the FDA?

Sniper (R) Spine System received FDA 510(k) clearance on 2016-02-26, under approval number K160003.

What company makes Sniper (R) Spine System?

Sniper (R) Spine System is manufactured by Spine Wave, Inc..

What is the FDA product code for Sniper (R) Spine System?

The FDA product code for Sniper (R) Spine System is MNI.

Related Clinical Trials

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Other Devices by Spine Wave, Inc.

K161993Leva® Anterior Interbody System K153222Leva Spacer System K152620Spine Wave Gen II Expandable Interbody System K172594Proficient® Posterior Cervical Spine System K173175Paramount Anterior Cervical Cage System K172175CapSure® PS System

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Related Devices (Code: MNI)

K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. K160320PremierShandong Weigao Orthopaedic Device Co., Ltd. K152324YAHUA Spinal SystemBeijing Weigao Yahua Artificial Joint Development Co. , Ltd.

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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