Genesys Spine AIS-C Cervical Stand-Alone System— 510(k) K181295

Substantially Equivalent

Genesys Spine

FDA 510(k) clearance K181295 for Genesys Spine AIS-C Cervical Stand-Alone System, Substantially Equivalent on 2018-08-29. Applicant: Genesys Spine.

Clearance details

Applicant: Genesys Spine
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2018-05-16
Decision date: 2018-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
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.