ENZA-A Titanium ALIF— 510(k) K173432

Clearance details

Applicant

Camber Spine Technologies

Product code

Code OVD

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2017-11-02

Decision date

2018-04-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wayne, PA, US

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• K221324 — ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)2023-03-30
• K223837 — SPIRA®-C Integrated Fixation System2023-03-22

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 →