NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System— 510(k) K203129

Substantially Equivalent

Precision Spine, Inc.

FDA 510(k) clearance K203129 for NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System, Substantially Equivalent on 2021-01-12. Applicant: Precision Spine, Inc..

Clearance details

Applicant: Precision Spine, Inc.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2020-10-19
Decision date: 2021-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pear, MS, 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.