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FDA 510(k)

Spine Wave Anterior Cervical Spine System

K-Number: K162760 · 2017-02-16

ApplicantSpine Wave, Inc.
Decision Date2017-02-16
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spine Wave Anterior Cervical Spine System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2017-02-16 under approval number K162760. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spine Wave Anterior Cervical Spine System?

Spine Wave Anterior Cervical Spine System is a medical device that received FDA 510(k) clearance on 2017-02-16. It is manufactured by Spine Wave, Inc.. The 510(k) number is K162760.

When was Spine Wave Anterior Cervical Spine System approved by the FDA?

Spine Wave Anterior Cervical Spine System received FDA 510(k) clearance on 2017-02-16, under approval number K162760.

What company makes Spine Wave Anterior Cervical Spine System?

Spine Wave Anterior Cervical Spine System is manufactured by Spine Wave, Inc..

What is the FDA product code for Spine Wave Anterior Cervical Spine System?

The FDA product code for Spine Wave Anterior Cervical Spine System is OVE.

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Other Devices by Spine Wave, Inc.

K161993Leva® Anterior Interbody System K153222Leva Spacer System K160003Sniper (R) Spine System K152620Spine Wave Gen II Expandable Interbody System K172594Proficient® Posterior Cervical Spine System K173175Paramount Anterior Cervical Cage System

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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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