FDA 510(k)

Hive Standalone Cervical System

K-Number: K223190 · 2022-12-12

Decision Date2022-12-12

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hive Standalone Cervical System is a medical device manufactured by NanoHive Medical, LLC. It received FDA 510(k) clearance on 2022-12-12 under approval number K223190. 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 Hive Standalone Cervical System?

Hive Standalone Cervical System is a medical device that received FDA 510(k) clearance on 2022-12-12. It is manufactured by NanoHive Medical, LLC. The 510(k) number is K223190.

When was Hive Standalone Cervical System approved by the FDA?

Hive Standalone Cervical System received FDA 510(k) clearance on 2022-12-12, under approval number K223190.

What company makes Hive Standalone Cervical System?

Hive Standalone Cervical System is manufactured by NanoHive Medical, LLC.

What is the FDA product code for Hive Standalone Cervical System?

The FDA product code for Hive Standalone Cervical System is OVE.

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Other Devices by NanoHive Medical, LLC

K231241NanoHive Medical Lumbar Interbody System K254105Hive Standalone Cervical System and Hive C Interbody System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.