Genesys Spine 3DP AIS-C II Cervical Interbody System— 510(k) K233594

Substantially Equivalent

Genesys Spine

FDA 510(k) clearance K233594 for Genesys Spine 3DP AIS-C II Cervical Interbody System, Substantially Equivalent on 2023-12-13. Applicant: Genesys Spine.

Clearance details

Applicant: Genesys Spine
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2023-11-08
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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.