The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Amistem-c.
| Device ID | K193433 |
| 510k Number | K193433 |
| Device Name: | AMIStem-C |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-10 |
| Decision Date | 2020-01-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971212541 | K193433 | 000 |