The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Amistem-h Proximal Coating, Amistem-p And Amistem-p Collared.
| Device ID | K173794 |
| 510k Number | K173794 |
| Device Name: | AMIStem-H Proximal Coating, AMIStem-P And AMIStem-P Collared |
| 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 | Elizabeth Rose Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, KY 40504 |
| 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 | 2017-12-14 |
| Decision Date | 2018-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030804342 | K173794 | 000 |
| 07630040720076 | K173794 | 000 |
| 07630040720083 | K173794 | 000 |
| 07630040720090 | K173794 | 000 |
| 07630040720106 | K173794 | 000 |
| 07630040720113 | K173794 | 000 |
| 07630040720120 | K173794 | 000 |
| 07630040720137 | K173794 | 000 |
| 07630040720144 | K173794 | 000 |
| 07630040720069 | K173794 | 000 |
| 07630040720052 | K173794 | 000 |
| 07630040720045 | K173794 | 000 |
| 07630030804359 | K173794 | 000 |
| 07630030804458 | K173794 | 000 |
| 07630040719988 | K173794 | 000 |
| 07630040719995 | K173794 | 000 |
| 07630040720007 | K173794 | 000 |
| 07630040720014 | K173794 | 000 |
| 07630040720021 | K173794 | 000 |
| 07630040720038 | K173794 | 000 |
| 07630040720151 | K173794 | 000 |
| 07630040720168 | K173794 | 000 |
| 07630040720175 | K173794 | 000 |
| 07630040720298 | K173794 | 000 |
| 07630040720304 | K173794 | 000 |
| 07630040720311 | K173794 | 000 |
| 07630040720328 | K173794 | 000 |
| 07630040720335 | K173794 | 000 |
| 07630040720342 | K173794 | 000 |
| 07630040720359 | K173794 | 000 |
| 07630040720366 | K173794 | 000 |
| 07630040720281 | K173794 | 000 |
| 07630040720274 | K173794 | 000 |
| 07630040720267 | K173794 | 000 |
| 07630040720182 | K173794 | 000 |
| 07630040720199 | K173794 | 000 |
| 07630040720205 | K173794 | 000 |
| 07630040720212 | K173794 | 000 |
| 07630040720229 | K173794 | 000 |
| 07630040720236 | K173794 | 000 |
| 07630040720243 | K173794 | 000 |
| 07630040720250 | K173794 | 000 |
| 07630040720373 | K173794 | 000 |