The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Moto Pfj System.
| Device ID | K200122 |
| 510k Number | K200122 |
| Device Name: | MOTO PFJ System |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| 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 | KRR |
| Subsequent Product Code | JWH |
| Subsequent Product Code | NPJ |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2020-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971262508 | K200122 | 000 |
| 07630040729987 | K200122 | 000 |
| 07630040729994 | K200122 | 000 |
| 07630040730006 | K200122 | 000 |
| 07630040730013 | K200122 | 000 |
| 07630040730020 | K200122 | 000 |
| 07630040730037 | K200122 | 000 |
| 07630040730044 | K200122 | 000 |
| 07630040730051 | K200122 | 000 |
| 07630040730068 | K200122 | 000 |
| 07630040730075 | K200122 | 000 |
| 07630040730082 | K200122 | 000 |
| 07630971262454 | K200122 | 000 |
| 07630971262461 | K200122 | 000 |
| 07630971262478 | K200122 | 000 |
| 07630971262485 | K200122 | 000 |
| 07630971262492 | K200122 | 000 |
| 07630040729970 | K200122 | 000 |