K191047 is an FDA 510(k) clearance for the ADI TiDAL Osteotomy Wedge. This device is classified as a Bone Wedge (Class II - Special Controls, product code PLF).
Submitted by Additive Device, Inc. (Adi) D/B/A Restor3D (Durham, US). The FDA issued a Cleared decision on November 5, 2019, 200 days after receiving the submission on April 19, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia..
| 510(k) Number | K191047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2019 |
| Decision Date | November 05, 2019 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PLF - Bone Wedge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| Definition | Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia. |