The following data is part of a premarket notification filed by Medacta International S .a. with the FDA for Amis K Long.
| Device ID | K220405 |
| 510k Number | K220405 |
| Device Name: | Amis K Long |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Medacta International S .A. 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 |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971265660 | K220405 | 000 |
| 07630971265547 | K220405 | 000 |
| 07630971265530 | K220405 | 000 |
| 07630971265523 | K220405 | 000 |
| 07630971265516 | K220405 | 000 |
| 07630971265509 | K220405 | 000 |
| 07630971265493 | K220405 | 000 |
| 07630971265486 | K220405 | 000 |
| 07630971265479 | K220405 | 000 |
| 07630971265554 | K220405 | 000 |
| 07630971265561 | K220405 | 000 |
| 07630971265578 | K220405 | 000 |
| 07630971265653 | K220405 | 000 |
| 07630971265646 | K220405 | 000 |
| 07630971265639 | K220405 | 000 |
| 07630971265622 | K220405 | 000 |
| 07630971265615 | K220405 | 000 |
| 07630971265608 | K220405 | 000 |
| 07630971265592 | K220405 | 000 |
| 07630971265585 | K220405 | 000 |
| 07630971265462 | K220405 | 000 |