The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mpact Extension.
| Device ID | K200391 |
| 510k Number | K200391 |
| Device Name: | MPACT Extension |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-18 |
| Decision Date | 2021-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971257566 | K200391 | 000 |
| 07630971257467 | K200391 | 000 |
| 07630971257474 | K200391 | 000 |
| 07630971257481 | K200391 | 000 |
| 07630971257498 | K200391 | 000 |
| 07630971257504 | K200391 | 000 |
| 07630971257511 | K200391 | 000 |
| 07630971257528 | K200391 | 000 |
| 07630971257535 | K200391 | 000 |
| 07630971257542 | K200391 | 000 |
| 07630971257559 | K200391 | 000 |
| 07630971257450 | K200391 | 000 |