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 |