Dakota ALIF System— 510(k) K213118

Substantially Equivalent

Precision Spine, Inc.

FDA 510(k) clearance K213118 for Dakota ALIF System, Substantially Equivalent on 2022-04-01. Applicant: Precision Spine, Inc..

Clearance details

Applicant: Precision Spine, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2021-09-27
Decision date: 2022-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pear, MS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.