The following data is part of a premarket notification filed by Implantcast, Gmbh with the FDA for Implantcast Ic-bipolar Head System.
| Device ID | K191569 |
| 510k Number | K191569 |
| Device Name: | Implantcast Ic-Bipolar Head System |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | Implantcast, GmbH Luneburger Schanze 26 Buxtehude, DE 21614 |
| Contact | Juliiane Hoppner |
| Correspondent | Dave Mcgurl Mcra, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | KWY |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-13 |
| Decision Date | 2019-08-28 |