Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies. It received FDA 510(k) clearance on 2018-12-07 under 510(k) 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. The listed applicant is Renovis Surgical Technologies. The 510(k) number is K182007.

When did Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System receive FDA 510(k) clearance?

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

Who is the listed applicant for Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System?

The FDA 510(k) record lists Renovis Surgical Technologies as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05740176The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion SurgeryACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITINGNCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITINGNCT07721493Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative DiseaseNOT_YET_RECRUITING

Other records listing Renovis Surgical Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemK181655Renovis S180 Lateral Lumbar Interbody Fusion SystemK180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemK171543Renovis Surgical Hip Replacement SystemK170888Renovis S141 Lumbar Interbody Fusion SystemK153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

View all 7 devices →

Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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.

↑