ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM— 510(k) K113518

Name: FDA 510(k) clearance K113518
Creator: U.S. Food and Drug Administration
Published: 2012-02-16

Substantially Equivalent

Spinefrontier, Inc.

FDA 510(k) clearance K113518 for ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM, Substantially Equivalent on 2012-02-16. Applicant: Spinefrontier, Inc.. Device class: 2.

Clearance details

Applicant: Spinefrontier, Inc.
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2011-11-29
Decision date: 2012-02-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.