The following data is part of a premarket notification filed by Neoortho Produtos Ortopedicos S/a with the FDA for Cannulated Screws Neoortho.
| Device ID | K162874 |
| 510k Number | K162874 |
| Device Name: | Cannulated Screws Neoortho |
| Classification | Screw, Fixation, Bone |
| Applicant | Neoortho Produtos Ortopedicos S/A Rus Angelo Domingos Durigan Curitiba, BR 82025-100 |
| Contact | Mariana De Oliveira Quinzani |
| Correspondent | Mariana De Oliveira Quinzani Neoortho Produtos Ortopedicos S/A Rua Angelo Domingos Durigan 607 Cascatinha Curitiba, BR 82025-100 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-13 |
| Decision Date | 2017-06-27 |
| Summary: | summary |