ADI Cervical Interbody Fusion Device— 510(k) K191812
Substantially EquivalentAdditive Device, Inc. (Adi) D/B/A Restor3D
FDA 510(k) clearance K191812 for ADI Cervical Interbody Fusion Device, Substantially Equivalent on 2019-10-24. Applicant: Additive Device, Inc. (Adi) D/B/A Restor3D.
Clearance details
- Applicant
- Additive Device, Inc. (Adi) D/B/A Restor3D
- Product code
- Code ODP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- 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, through . 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.