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FDA 510(k)

Cavetto-SA Cervical Cage System

K-Number: K200115 · 2020-09-24

ApplicantNeurostructures, Inc.
Decision Date2020-09-24
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cavetto-SA Cervical Cage System is a medical device manufactured by Neurostructures, Inc.. It received FDA 510(k) clearance on 2020-09-24 under approval number K200115. 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 Cavetto-SA Cervical Cage System?

Cavetto-SA Cervical Cage System is a medical device that received FDA 510(k) clearance on 2020-09-24. It is manufactured by Neurostructures, Inc.. The 510(k) number is K200115.

When was Cavetto-SA Cervical Cage System approved by the FDA?

Cavetto-SA Cervical Cage System received FDA 510(k) clearance on 2020-09-24, under approval number K200115.

What company makes Cavetto-SA Cervical Cage System?

Cavetto-SA Cervical Cage System is manufactured by Neurostructures, Inc..

What is the FDA product code for Cavetto-SA Cervical Cage System?

The FDA product code for Cavetto-SA Cervical Cage System is OVE.

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Other Devices by Neurostructures, Inc.

K153097Belvedere™ Lateral Plating System K171914Cortina™ Lumbar Cage System K171112Trifore(tm) Cervical Plating System K182195Arco™-SA Lumbar Cage System K181590Neurostructures Cavetto® [MAX] Cervical Cage System K173082Arco™-SA Lumbar Cage System

View all 13 devices →

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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