The following data is part of a De Novo classification by Woven Orthopedic Technologies, Llc with the FDA for Ogmend Implant System.
| DeNovo ID | DEN180065 |
| Device Name: | OGmend Implant System |
| Classification | Screw Sleeve Bone Fixation Device |
| Applicant | Woven Orthopedic Technologies, LLC 63 E. Center Street Manchester, CT 06040 |
| Contact | Bob Luzzi |
| Product Code | QAC |
| CFR Regulation Number | 888.3043 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Orthopedic |
| Classification Advisory | Orthopedic |
| Type | Direct |
| Date Received | 2018-12-13 |
| Decision Date | 2020-05-01 |
| Reclassification Order: | Reclassification Order |