The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M.u.s.t. Sacral Iliac Screw And Pelvic Trauma System.
| Device ID | K203671 |
| 510k Number | K203671 |
| Device Name: | M.U.S.T. Sacral Iliac Screw And Pelvic Trauma System |
| Classification | Sacroiliac Joint Fixation |
| 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 | OUR |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-16 |
| Decision Date | 2021-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345701275 | K203671 | 000 |
| 07630345701145 | K203671 | 000 |
| 07630345701152 | K203671 | 000 |
| 07630345701169 | K203671 | 000 |
| 07630345701176 | K203671 | 000 |
| 07630345701183 | K203671 | 000 |
| 07630345701190 | K203671 | 000 |
| 07630345701206 | K203671 | 000 |
| 07630345701213 | K203671 | 000 |
| 07630345701220 | K203671 | 000 |
| 07630345701237 | K203671 | 000 |
| 07630345701244 | K203671 | 000 |
| 07630345701251 | K203671 | 000 |
| 07630345701268 | K203671 | 000 |
| 07630345701138 | K203671 | 000 |