ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)— 510(k) K221324

Substantially Equivalent

Camber Spine Technologies

FDA 510(k) clearance K221324 for ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF), Substantially Equivalent on 2023-03-30. Applicant: Camber Spine Technologies.

Clearance details

Applicant: Camber Spine Technologies
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2022-05-06
Decision date: 2023-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, 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.