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FDA 510(k)

Genesys Spine AIS-C Cervical Stand-Alone System

K-Number: K181295 · 2018-08-29

ApplicantGenesys Spine
Decision Date2018-08-29
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine AIS-C Cervical Stand-Alone System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2018-08-29 under approval number K181295. 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 Genesys Spine AIS-C Cervical Stand-Alone System?

Genesys Spine AIS-C Cervical Stand-Alone System is a medical device that received FDA 510(k) clearance on 2018-08-29. It is manufactured by Genesys Spine. The 510(k) number is K181295.

When was Genesys Spine AIS-C Cervical Stand-Alone System approved by the FDA?

Genesys Spine AIS-C Cervical Stand-Alone System received FDA 510(k) clearance on 2018-08-29, under approval number K181295.

What company makes Genesys Spine AIS-C Cervical Stand-Alone System?

Genesys Spine AIS-C Cervical Stand-Alone System is manufactured by Genesys Spine.

What is the FDA product code for Genesys Spine AIS-C Cervical Stand-Alone System?

The FDA product code for Genesys Spine AIS-C Cervical Stand-Alone System is OVE.

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Other Devices by Genesys Spine

K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion System K161914Genesys Spine TiLock Cortical Spinal System K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion System K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion System K153123Genesys Spine Apache Interbody Fusion System K172469TiLock Modular Spinal 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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