The following data is part of a premarket notification filed by Medacta International with the FDA for Mpact Double Mobility System.
| Device ID | K143453 |
| 510k Number | K143453 |
| Device Name: | Mpact Double Mobility System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Medacta International Strauda Regina Castel San Pietro, CH Ch 6874 |
| Contact | Adam Gross |
| Correspondent | Adam Gross Medacta USA 1556 W Carroll Ave Chicago, IL 60607 |
| 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 | 2014-12-03 |
| Decision Date | 2015-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030861048 | K143453 | 000 |
| 07630030806780 | K143453 | 000 |
| 07630030860928 | K143453 | 000 |
| 07630030860935 | K143453 | 000 |
| 07630030860942 | K143453 | 000 |
| 07630030860959 | K143453 | 000 |
| 07630030860966 | K143453 | 000 |
| 07630030860973 | K143453 | 000 |
| 07630030860980 | K143453 | 000 |
| 07630030860997 | K143453 | 000 |
| 07630030861000 | K143453 | 000 |
| 07630030861017 | K143453 | 000 |
| 07630030861024 | K143453 | 000 |
| 07630030861031 | K143453 | 000 |
| 07630030806773 | K143453 | 000 |