The following data is part of a premarket notification filed by Fx Shoulder Usa, Inc. with the FDA for Glenoid Baseplate With Screw.
| Device ID | K192799 |
| 510k Number | K192799 |
| Device Name: | Glenoid Baseplate With Screw |
| 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 |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701037313374 | K192799 | 000 |
| 03701037313367 | K192799 | 000 |
| 03701037313350 | K192799 | 000 |
| 03701037313343 | K192799 | 000 |
| 03701037313336 | K192799 | 000 |
| 03701037313329 | K192799 | 000 |
| 03701037313312 | K192799 | 000 |
| 03701037313305 | K192799 | 000 |