The following data is part of a premarket notification filed by Delphos Implants - Ind.com. Importacao E Exportacao De with the FDA for Delphos Implants Rigid Fixation System.
| Device ID | K182609 |
| 510k Number | K182609 |
| Device Name: | Delphos Implants Rigid Fixation System |
| Classification | Plate, Bone |
| Applicant | Delphos Implants - Ind.Com. Importacao E Exportacao De Implants Medicos S.A Estrada Manuel Correia Lopes, Parque Empresarial Progresso, Armazem. No5 Cascais, PT 2785-126 |
| Contact | Vitor Monsanto |
| Correspondent | Mauro Malzyner Passarini Regulatory Affairs Of America, LLC 201 S. Biscayne Blvd, Suite 1200 Miami, FL 33131 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-21 |
| Decision Date | 2019-03-29 |