The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Amistem-p Short Neck.
| Device ID | K192126 |
| 510k Number | K192126 |
| Device Name: | AMIStem-P Short Neck |
| 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 | 2019-08-06 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971243828 | K192126 | 000 |
| 07630971243712 | K192126 | 000 |
| 07630971243705 | K192126 | 000 |
| 07630971243699 | K192126 | 000 |
| 07630971243682 | K192126 | 000 |
| 07630971243675 | K192126 | 000 |
| 07630971243668 | K192126 | 000 |
| 07630971243651 | K192126 | 000 |
| 07630971243644 | K192126 | 000 |
| 07630971243729 | K192126 | 000 |
| 07630971243736 | K192126 | 000 |
| 07630971243811 | K192126 | 000 |
| 07630971243804 | K192126 | 000 |
| 07630971243798 | K192126 | 000 |
| 07630971243781 | K192126 | 000 |
| 07630971243774 | K192126 | 000 |
| 07630971243767 | K192126 | 000 |
| 07630971243750 | K192126 | 000 |
| 07630971243743 | K192126 | 000 |
| 07630971243637 | K192126 | 000 |