ClariVy Cervical IBF System— 510(k) K230414

Substantially Equivalent

Vy Spine, LLC

FDA 510(k) clearance K230414 for ClariVy Cervical IBF System, Substantially Equivalent on 2023-05-12. Applicant: Vy Spine, LLC.

Clearance details

Applicant: Vy Spine, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2023-02-16
Decision date: 2023-05-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Tallahassee, FL, US

Download summary PDF View on FDA.gov ↗

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.