The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Amistem-h Proximal Coating.
| Device ID | K161635 |
| 510k Number | K161635 |
| Device Name: | AMIStem-H Proximal Coating |
| 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 | Stefano Baj Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Castel San Pietro, CH |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-14 |
| Decision Date | 2017-03-31 |
| Summary: | summary |