The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Glenoid Polyaxial Non-locking Screws.
| Device ID | K181826 |
| 510k Number | K181826 |
| Device Name: | Glenoid Polyaxial Non-locking Screws |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| 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 | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2018-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040719964 | K181826 | 000 |
| 07630040719889 | K181826 | 000 |
| 07630040719896 | K181826 | 000 |
| 07630040719902 | K181826 | 000 |
| 07630040719919 | K181826 | 000 |
| 07630040719926 | K181826 | 000 |
| 07630040719933 | K181826 | 000 |
| 07630040719940 | K181826 | 000 |
| 07630040719957 | K181826 | 000 |
| 07630040719872 | K181826 | 000 |