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FDA 510(k)

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System

K-Number: K182007 · 2018-12-07

ApplicantRenovis Surgical Technologies
Decision Date2018-12-07
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is a medical device manufactured by Renovis Surgical Technologies. It received FDA 510(k) clearance on 2018-12-07 under approval number K182007. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System?

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is a medical device that received FDA 510(k) clearance on 2018-12-07. It is manufactured by Renovis Surgical Technologies. The 510(k) number is K182007.

When was Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System approved by the FDA?

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System received FDA 510(k) clearance on 2018-12-07, under approval number K182007.

What company makes Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System?

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is manufactured by Renovis Surgical Technologies.

What is the FDA product code for Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System?

The FDA product code for Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is OVD.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Renovis Surgical Technologies

K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System K171543Renovis Surgical Hip Replacement System K170888Renovis S141 Lumbar Interbody Fusion System K181655Renovis S180 Lateral Lumbar Interbody Fusion System K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee System

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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