K191812

Substantially Equivalent

ADI Cervical Interbody Fusion Device

Applicant: Additive Device, Inc. (Adi) D/B/A Restor3D
Product code: ODP
Advisory panel: Orthopedic
Date received: 2019-07-05
Decision date: 2019-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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.