The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Dm Converter - Tin Coated.
| Device ID | K211891 |
| 510k Number | K211891 |
| Device Name: | DM Converter - TiN Coated |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Medacta International S.A. Strada Regina Castel San Pietro, CH CH-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2022-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971256392 | K211891 | 000 |
| 07630971256385 | K211891 | 000 |
| 07630971256378 | K211891 | 000 |
| 07630971256361 | K211891 | 000 |
| 07630971256354 | K211891 | 000 |
| 07630971256347 | K211891 | 000 |