The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Sms Cementless Stem.
| Device ID | K203041 |
| 510k Number | K203041 |
| Device Name: | SMS Cementless Stem |
| 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 |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-06 |
| Decision Date | 2020-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345701978 | K203041 | 000 |
| 07630345701817 | K203041 | 000 |
| 07630345701800 | K203041 | 000 |
| 07630345701794 | K203041 | 000 |
| 07630345701787 | K203041 | 000 |
| 07630345701770 | K203041 | 000 |
| 07630345701763 | K203041 | 000 |
| 07630345701756 | K203041 | 000 |
| 07630345701749 | K203041 | 000 |
| 07630345701732 | K203041 | 000 |
| 07630345701725 | K203041 | 000 |
| 07630345701718 | K203041 | 000 |
| 07630345701701 | K203041 | 000 |
| 07630345701695 | K203041 | 000 |
| 07630345701824 | K203041 | 000 |
| 07630345701831 | K203041 | 000 |
| 07630345701961 | K203041 | 000 |
| 07630345701954 | K203041 | 000 |
| 07630345701947 | K203041 | 000 |
| 07630345701930 | K203041 | 000 |
| 07630345701923 | K203041 | 000 |
| 07630345701916 | K203041 | 000 |
| 07630345701909 | K203041 | 000 |
| 07630345701893 | K203041 | 000 |
| 07630345701886 | K203041 | 000 |
| 07630345701879 | K203041 | 000 |
| 07630345701862 | K203041 | 000 |
| 07630345701855 | K203041 | 000 |
| 07630345701848 | K203041 | 000 |
| 07630345701688 | K203041 | 000 |