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FDA 510(k)

Romero Cervical Cage

K-Number: K212358 · 2022-01-10

ApplicantSpineup, Inc.
Decision Date2022-01-10
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Romero Cervical Cage is a medical device manufactured by Spineup, Inc.. It received FDA 510(k) clearance on 2022-01-10 under approval number K212358. 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 Romero Cervical Cage?

Romero Cervical Cage is a medical device that received FDA 510(k) clearance on 2022-01-10. It is manufactured by Spineup, Inc.. The 510(k) number is K212358.

When was Romero Cervical Cage approved by the FDA?

Romero Cervical Cage received FDA 510(k) clearance on 2022-01-10, under approval number K212358.

What company makes Romero Cervical Cage?

Romero Cervical Cage is manufactured by Spineup, Inc..

What is the FDA product code for Romero Cervical Cage?

The FDA product code for Romero Cervical Cage is OVE.

Other Devices by Spineup, Inc.

K250446Frida™ Anterior Cervical Plate 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

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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