K152099

Substantially Equivalent

Genesys Spine Apache® Anchored Cervical Interbody Fusion System

Applicant: Genesys Spine
Product code: OVE
Advisory panel: Orthopedic
Date received: 2015-07-28
Decision date: 2016-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.