The following data is part of a premarket notification filed by Implantcast Gmbh with the FDA for Ecofit Vit E Acetabular System.
| Device ID | K180263 |
| 510k Number | K180263 |
| Device Name: | EcoFit Vit E Acetabular System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | implantcast Gmbh Lueneburger Schanze 26 Buxtehude, DE 21614 |
| Contact | Juliane Hoeppner |
| Correspondent | Dave Mcgurl Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-30 |
| Decision Date | 2018-07-20 |
| Summary: | summary |