The following data is part of a premarket notification filed by Implantcast, Gmbh with the FDA for Mutars Cemented Femoral Stems.
| Device ID | K200045 |
| 510k Number | K200045 |
| Device Name: | MUTARS Cemented Femoral Stems |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | implantcast, GmbH Luneburger Schanze 26 21614, DE |
| Contact | Juliane Hoppner |
| Correspondent | Lindsay Kleinwaks MCRA, LLC 1050 K Street NW Suite 1000 Washington, DC 20005 |
| Product Code | MEH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-08 |
| Decision Date | 2020-10-16 |