The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Sms Cementless Stem.
| Device ID | K201673 |
| 510k Number | K201673 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-19 |
| Decision Date | 2020-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971292062 | K201673 | 000 |
| 07630971292055 | K201673 | 000 |
| 07630971292048 | K201673 | 000 |
| 07630971292031 | K201673 | 000 |
| 07630971292024 | K201673 | 000 |
| 07630971292017 | K201673 | 000 |
| 07630971292000 | K201673 | 000 |
| 07630971291997 | K201673 | 000 |