The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Medacta Shoulder System Short Humeral Diaphysis.
| Device ID | K180089 |
| 510k Number | K180089 |
| Device Name: | Medacta Shoulder System Short Humeral Diaphysis |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Elizabeth Rose Mapi USA, Inc. 2343 Alexandria Drive Suite 100 Lexington, KY 40504 |
| Product Code | PHX |
| 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 | 2018-01-12 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040715973 | K180089 | 000 |
| 07630040715881 | K180089 | 000 |
| 07630040715898 | K180089 | 000 |
| 07630040715904 | K180089 | 000 |
| 07630040715911 | K180089 | 000 |
| 07630040715928 | K180089 | 000 |
| 07630040715935 | K180089 | 000 |
| 07630040715942 | K180089 | 000 |
| 07630040715959 | K180089 | 000 |
| 07630040715966 | K180089 | 000 |
| 07630040715874 | K180089 | 000 |