The following data is part of a premarket notification filed by Fx Shoulder Usa, Inc. with the FDA for 32mm Glenosphere And Humeral Cup.
| Device ID | K192206 |
| 510k Number | K192206 |
| Device Name: | 32mm Glenosphere And Humeral Cup |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas, TX 75244 |
| Contact | Kathy Trier |
| Correspondent | Kathy Trier FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas, TX 75244 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-14 |
| Decision Date | 2019-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701037309377 | K192206 | 000 |
| 03701037309360 | K192206 | 000 |
| 03701037309353 | K192206 | 000 |
| 03701037309483 | K192206 | 000 |
| 03701037309476 | K192206 | 000 |
| 03701037310588 | K192206 | 000 |