The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Sms Femoral Stem.
| Device ID | K181693 |
| 510k Number | K181693 |
| Device Name: | SMS Femoral 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 | 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 | 2018-06-27 |
| Decision Date | 2018-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030888854 | K181693 | 000 |
| 07630030888717 | K181693 | 000 |
| 07630030888700 | K181693 | 000 |
| 07630030888694 | K181693 | 000 |
| 07630030888687 | K181693 | 000 |
| 07630030888670 | K181693 | 000 |
| 07630030888663 | K181693 | 000 |
| 07630030888656 | K181693 | 000 |
| 07630030888649 | K181693 | 000 |
| 07630030888632 | K181693 | 000 |
| 07630030888724 | K181693 | 000 |
| 07630030888755 | K181693 | 000 |
| 07630030888847 | K181693 | 000 |
| 07630030888830 | K181693 | 000 |
| 07630030888823 | K181693 | 000 |
| 07630030888816 | K181693 | 000 |
| 07630030888809 | K181693 | 000 |
| 07630030888793 | K181693 | 000 |
| 07630030888786 | K181693 | 000 |
| 07630030888779 | K181693 | 000 |
| 07630030888762 | K181693 | 000 |
| 07630030888625 | K181693 | 000 |