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FDA 510(k)

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

K-Number: K153250 · 2016-03-16

ApplicantRenovis Surgical Technologies
Decision Date2016-03-16
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is a medical device manufactured by Renovis Surgical Technologies. It received FDA 510(k) clearance on 2016-03-16 under approval number K153250. 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 Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System?

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is a medical device that received FDA 510(k) clearance on 2016-03-16. It is manufactured by Renovis Surgical Technologies. The 510(k) number is K153250.

When was Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System approved by the FDA?

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System received FDA 510(k) clearance on 2016-03-16, under approval number K153250.

What company makes Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System?

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is manufactured by Renovis Surgical Technologies.

What is the FDA product code for Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System?

The FDA product code for Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is OVE.

Related Clinical Trials

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Other Devices by Renovis Surgical Technologies

K171543Renovis Surgical Hip Replacement System K170888Renovis S141 Lumbar Interbody Fusion System K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System K181655Renovis S180 Lateral Lumbar Interbody Fusion System K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee 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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