ENZA-A Titanium ALIF— 510(k) K173432

Substantially Equivalent

Camber Spine Technologies

FDA 510(k) clearance K173432 for ENZA-A Titanium ALIF, Substantially Equivalent on 2018-04-18. Applicant: Camber Spine Technologies.

Clearance details

Applicant: Camber Spine Technologies
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2017-11-02
Decision date: 2018-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, 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.