Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System— 510(k) K153250

Substantially Equivalent

Renovis Surgical Technologies

FDA 510(k) clearance K153250 for Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System, Substantially Equivalent on 2016-03-16. Applicant: Renovis Surgical Technologies.

Clearance details

Applicant: Renovis Surgical Technologies
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2015-11-09
Decision date: 2016-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.