The following data is part of a premarket notification filed by Fx Shoulder Usa, Inc. with the FDA for Humelock Tin Coated Glenosphere.
| Device ID | K191146 |
| 510k Number | K191146 |
| Device Name: | Humelock TiN Coated Glenosphere |
| 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 | 2019-04-30 |
| Decision Date | 2020-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701037300855 | K191146 | 000 |
| 03701037300848 | K191146 | 000 |
| 03701037300817 | K191146 | 000 |
| 03701037300800 | K191146 | 000 |
| 03701037309551 | K191146 | 000 |
| 03701037309568 | K191146 | 000 |