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FDA 510(k)

Unispace SA Cervical Cage

K-Number: K213791 · 2022-08-05

ApplicantEdisoninno Co., Ltd.
Decision Date2022-08-05
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Unispace SA Cervical Cage is a medical device manufactured by Edisoninno Co., Ltd.. It received FDA 510(k) clearance on 2022-08-05 under approval number K213791. 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 Unispace SA Cervical Cage?

Unispace SA Cervical Cage is a medical device that received FDA 510(k) clearance on 2022-08-05. It is manufactured by Edisoninno Co., Ltd.. The 510(k) number is K213791.

When was Unispace SA Cervical Cage approved by the FDA?

Unispace SA Cervical Cage received FDA 510(k) clearance on 2022-08-05, under approval number K213791.

What company makes Unispace SA Cervical Cage?

Unispace SA Cervical Cage is manufactured by Edisoninno Co., Ltd..

What is the FDA product code for Unispace SA Cervical Cage?

The FDA product code for Unispace SA Cervical Cage is OVE.

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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