The following data is part of a premarket notification filed by Medacta International Sa with the FDA for 3dmetal Diaphyseal Femoral Cones.
| Device ID | K200075 |
| 510k Number | K200075 |
| Device Name: | 3DMetal Diaphyseal Femoral Cones |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH 6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-14 |
| Decision Date | 2020-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971259249 | K200075 | 000 |
| 07630971259232 | K200075 | 000 |
| 07630971259225 | K200075 | 000 |
| 07630971259218 | K200075 | 000 |