ADI TiDAL Osteotomy Wedge— 510(k) K191047
Substantially EquivalentAdditive Device, Inc. (Adi) D/B/A Restor3D
FDA 510(k) clearance K191047 for ADI TiDAL Osteotomy Wedge, Substantially Equivalent on 2019-11-05. Applicant: Additive Device, Inc. (Adi) D/B/A Restor3D.
Clearance details
- Applicant
- Additive Device, Inc. (Adi) D/B/A Restor3D
- Product code
- Code PLF
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.