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

Name: FDA 510(k) clearance K203129
Creator: U.S. Food and Drug Administration
Published: 2021-01-12

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.. Device class: 2.

Clearance details

Applicant: Precision Spine, Inc.
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

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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.