K113518

Substantially Equivalent

ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM

Applicant: Spinefrontier, Inc.
Product code: ODP
Advisory panel: Orthopedic
Date received: 2011-11-29
Decision date: 2012-02-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Beverly, MA, US

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.