510(k) K162694— Ayers Rock Cervical interbody fusion system

Substantially Equivalent

Spineway

Clearance details

Applicant: Spineway
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2016-09-27
Decision date: 2017-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ecully, FR

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.