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FDA 510(k)

Cervical Stand Alone System

K-Number: K161280 · 2016-06-17

ApplicantOrthofix, Inc.
Decision Date2016-06-17
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Stand Alone System is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2016-06-17 under approval number K161280. 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 Cervical Stand Alone System?

Cervical Stand Alone System is a medical device that received FDA 510(k) clearance on 2016-06-17. It is manufactured by Orthofix, Inc.. The 510(k) number is K161280.

When was Cervical Stand Alone System approved by the FDA?

Cervical Stand Alone System received FDA 510(k) clearance on 2016-06-17, under approval number K161280.

What company makes Cervical Stand Alone System?

Cervical Stand Alone System is manufactured by Orthofix, Inc..

What is the FDA product code for Cervical Stand Alone System?

The FDA product code for Cervical Stand Alone System is OVE.

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Other Devices by Orthofix, Inc.

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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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